Sutures vs. Adhesive Strips in Lumbar Spinal Fusion: Propensity-Matched Non-Inferiority Retrospective Analysis of Surgical Site Infections

Sutures vs. Adhesive Strips in Lumbar Spinal Fusion: Propensity-Matched Non-Inferiority Retrospective Analysis of Surgical Site Infections | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Sutures vs. Adhesive Strips in Lumbar Spinal Fusion: Propensity-Matched Non-Inferiority Retrospective Analysis of Surgical Site Infections Fernando Alonso Núñez Moreno, Christian Bepperling, Carlos Trenado, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6123787/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose : To compare surgical site infection rates between adhesive strips and sutures in lumbar spinal fusion surgery, using a non-inferiority margin. Methods : This single-center retrospective study compared surgical site infection (SSI) rates between sutures and adhesive strips in lumbar spinal fusion using propensity score matching (PSM) and a 3% non-inferiority margin. Patients undergoing one- or two-level lumbar fusion via an open posterior approach between 2019 and 2022 were included. Data were extracted from a prospectively maintained database, and postoperative SSIs were classified using the KISS surveillance system. Exclusion criteria included patients under 18, pre-existing infections, revision surgeries, and deep organ/space infections. PSM balanced covariates such as age, gender, ASA classification, surgical time, use of drainage, and the number of levels fused. A total of 997 patient records were analyzed. After applying PSM, 608 patients were evenly divided into two groups. Statistical analysis included t-tests, Mann-Whitney U tests, chi-square tests, and a Wald test for non-inferiority, rejecting the null hypothesis if the 95% one-sided confidence interval remained below the 3% margin. Results : Following PSM, infection rates were 1.64% for sutures and 1.97% for adhesive strips. A one-sided Wald test with a 3% non-inferiority margin produced an absolute risk difference of 0.33% (SE 1.1%; z = –2.47; one-sided p = 0.0067) and an upper 95% CI bound of 2.11%. Conclusions : Adhesive strips are non-inferior to sutures in SSI rates for one or two level lumbar spinal fusion. Registered at ClinicalTrials.gov Identifier NCT06664424 on October 15, 2024. Lumbar Spinal Fusion Surgical Site Infections Adhesive Strips Adhesive Tape Spine Surgery Non-inferiority Study Spondylodesis Figures Figure 1 Figure 2 Introduction Surgical site infections (SSIs) are among the most common complications in spine surgery, with a meta-analysis estimating an average SSI rate of approximately 2.7% in lumbar spine surgery.[ 1 ] For lumbar spinal fusion, the incidence ranges from 1.9–4.48%, influenced by patient characteristics and risk factors.[ 2 – 4 ] The selection of materials for skin closure in posterior spine surgery have been shown to impact the rates of SSI.[ 5 ] Currently sutures are the standard wound closure method in spine surgery, serving as the benchmark for comparison with other techniques. Emerging alternatives such as staples and tissue adhesives, have demonstrated advantages, including faster closure and shorter hospital stays, while maintaining comparable SSI rates.[ 5 – 7 ] Among emerging wound closure methods, adhesive strips (Omnistrip™; Hartmann, Sontheim, Germany), a type of adhesive tape, have undergone minimal evaluation, particularly for large wounds in spinal surgery. Our institution has utilized adhesive strips since 2017, with increased adoption during the COVID-19 pandemic to reduce patient-healthcare worker interaction. The observed benefits include shorter surgical duration, fewer postoperative visits, and improved cosmetic outcomes without an increase in wound-related complications led to their expanded use in larger wounds. This study aimed to compare SSI rates between sutures and adhesive strips in large surgical wounds, specifically in posterior one- and two-level open lumbar spinal fusion, using a non-inferiority analysis. Methods Study design This retrospective single-center study employed propensity score matching (PSM) and non-inferiority analysis to compare sutures and adhesive strips for skin closure, with SSI rates as the primary outcome. Settings It included patients who underwent one- or two-level lumbar spinal fusion via an open posterior approach at the Spine Center of Diakonie-Klinikum Stuttgart. Data were collected from 2019 to 2022 using the institution’s prospectively maintained database, which systematically tracks SSIs in treated patients. This study was approved by the ethic commission of the state medical association of Baden-Württemberg (F-2024-077). Postoperative follow-up was conducted through structured consultations to assess clinical status and wound healing. SSIs were diagnosed based on clinical signs of infection and confirmed by positive wound cultures, with severity classified according to the KISS surveillance protocol (A1: superficial, A2: deep, A3: organ/space). [8] Participants Patients included in the analysis underwent skin closure with either sutures (absorbable or non-absorbable) or adhesive strips and underwent open posterior spinal fusion of one or two segments. Exclusion criteria comprised patients under 18 years old, those with pre-existing surgical site infections (e.g., spondylodiscitis), surgeries other than open posterior spinal fusion, revision procedures for non-wound complications (e.g., pedicle screw or interbody cage fracture), infections classified as A3, endoscopic procedures, and surgeries involving more than two vertebral segments. Only SSIs occurring within 30 days post-surgery were analyzed, focusing exclusively on superficial infections, as deeper infections were unlikely to be influenced by the wound closure method. The surgical technique included fascial closure and subcutaneous tissue approximation, both performed using a standard interrupted suture technique with absorbable sutures in both groups. For skin closure, two methods were used: in the suture group, wounds were closed with either interrupted transcutaneous stitches using non-absorbable sutures or an absorbable subcuticular technique; in the adhesive strip group, wound edges were manually approximated before the sequential application of adhesive strips see figure 1. Seven surgeons performed all closures, maintaining a consistent surgical technique throughout the study period. The use of adhesive strips increased gradually over time, with the same surgeons overseeing both wound closure and postoperative follow-up. Propensity score matching The data was analyzed before matching to obtain general insights and establish a baseline for comparison. To minimize selection bias in the final analysis, a PSM approach was applied. The propensity score was estimated using a logistic regression model, with the type of wound closure material as the dependent variable. Covariates included gender, age, ASA classification, surgical time, use of drainage, and the number of surgical segments intervened. Nearest neighbor matching without replacement was performed using a caliper width of 0.2 times the standard deviation of the logit of the propensity score. After matching, all standardized mean differences (SMDs) were below 0.15, indicating an acceptable balance between groups: gender (SMD = 0.1092), age (SMD = 0.0007), surgical time (SMD = -0.1466), use of surgical drains (SMD = 0.1244), and number of segments (SMD = -0.0667). Statistical analysis All statistical analyses and graphical representations were conducted using IBM SPSS Statistics Version 25 (RRID:SCR_002865), R (RRID:SCR_001905), and Matlab Version 9.12 (RRID:SCR_001622). Frequencies and proportions were calculated, along with their 95% confidence intervals (CI). To assess normality of quantitative data a Shapiro-Wilk test was performed. Based on the results, an independent t-test was employed for normally distributed data, while a Mann-Whitney U test was conducted for non-parametric distributions. Chi-square test was employed for the analysis of categorical data, for ordinal data a Cochran-Armitage test for trend was employed. The null hypothesis was rejected if the p-value was less than 0.05. Non-inferiority margin Non-inferiority was assessed using a Wald test with a 3% non-inferiority margin. The null hypothesis was rejected if the upper bound of the 95% one-sided confidence interval for the absolute risk difference remained below this threshold. This 3% margin is considered conservative in the context of wound infections, as previous studies have adopted wider margins of up to 10%.[9–12] H o : p 1 -p 2 ≥ δ p1 : Adhesive strips group rate of SSIs. Ha: p 1 -p 2 ≤ δ p2: Suture group rate of SSIs δ=0.03 Results A total of 1016 patients were identified over a four-year period, with an overall infection rate of 2.84% (A1, A2 and A3). Patients diagnosed with A3 infections (13 patients) were excluded from the analysis, as it was assumed that the presence of these infections were not affected by the wound closure techniques being evaluated. From the resulting 1003 patient records six more patients were eliminated from the analysis due to lack of complete data. Finally, 997 patients were included in the analysis in which 346 (34%) patients were treated with suture and 651 with adhesive strips (65%). Baseline characteristics of the population are described in table 1. In summary, there was statistical difference in gender distribution (p 0.029), surgical time (p<0.001), hospital stay (p<0.001), ASA score (p<0.001) and utilization of surgical drains (p<0.001). Table 1 . Demographic and surgical characteristics before propensity score matching. ASA , American Society of Anesthesiologists Physical Status Classification System, SD , Standard Deviation, a, surgical time is expressed in minutes, b, Length of stay is expressed in days, statistically significant difference (*). Patients characteristics Suture Adhesive strips p Age (SD) 66.9(13.11) 66.9(13.26) 0.27 Gender (%) 0.029* Female 244(70.5) 413(63.4) Male 102(29.5) 238(36.5) Surgical time a (SD) 132.2 (43.25) 116.2(40.5) 2.34E-08* Length of stay b (SD) 8.8 (5.03) 7.5(5.2) 2.31E-20* Segments (%) 0.065 1 233(67.3) 476(73.1) 2 113(32.65) 175(26.8) Use of surgical drains (%) 1.01E-16* Yes 175(50.5) 499(76.6) No 171(49.4) 152(23.3) ASA (%) 2.01E-05* I 15(4.3) 13(1.9) II 237(68.4) 380(58.37) III 94(27.1) 257(39.4) IV 0 1(0.1) V 0 0 VI 0 0 To control differences in the cohort a PSM was performed. The matching process excluded 347 patients from the adhesive strips group and 42 patients from the sutures group. The final cohorts consisted of 304 patients in each group with differences balanced with the exception of length of stay (p<0.001). The characteristics of the matched cohort are shown in table 2. Table 2 Demographics and surgical characteristics after propensity score matching. ASA , American Society of Anesthesiologists Physical Status Classification System, SD , Standard Deviation, a, surgical time is expressed in minutes, b, Length of stay is expressed in days, statistically significant difference (*). Patients characteristics Sutures Adhesive strips p Age (SD) 66.9(13.3) 66.9(13.1) 0.906 Gender (%) 0.198 Female 209(68.7) 193(63.4) Male 95(31.2) 111(36.5) Surgical time a (SD) 127.1(41.1) 121.2(43.1) 0.065 Length of stay b (SD) 8.8(5.1) 7.2(4.4) 7.92673e-16* Segments (%) 0.467 1 216(71.9) 225(74.0) 2 88(28.9) 79(25.9) Use of surgical drains (%) 0.213 Yes 175(57.5) 191(62.8) No 129(42.4) 113(37.1) ASA (%) 0.579 I 11(3.6) 7(2.3) II 199(65.4) 200(65.7) III 94(30.9) 97(31.9) IV 0 0 V 0 0 VI 0 0 SSIs rate and non-inferiority. After PSM SSI rates were 1.64% (95% CI: 0.70 – 3.79%) for sutures and 1.97% (95% CI: 0.91 – 4.24%) for adhesive strips (Figure 2). The one-sided Wald test using a 3% non-inferiority margin yielded a risk difference of 0.33% (SE = 1.1%), with z = –2.47 and a one-sided p-value of 0.0067. The upper bound of the 95% one-sided confidence interval for the absolute risk difference was 2.11%, below the 3% margin. Discussion The results of this study supports the use of adhesive strips as a comparable alternative to sutures for wound closure in open posterior one- and two-level lumbar spinal fusion, with similar SSI rates. Statistical analysis demonstrated a 0.33% difference in SSI rates, establishing non-inferiority within a 3% absolute risk difference margin. The comparable SSI rates between adhesive strips and sutures in our data are consistent with findings from other studies. Yang et al. conducted a small retrospective study of 36 patients who underwent percutaneous vertebroplasty with 1.5–2 cm incisions to assess wound complications. Adhesive tapes were used in 91.6% of cases, while 8.3% received sutures. No SSIs were observed in either group, and complications occurred in only one patient in the adhesive tape group, related to bleeding.[13] A larger retrospective study sponsored by Ethicon employing a similar method investigated the Dermabond Prineo-Skin Closure System (Ethicon Inc., NJ, USA). This system integrates 2‑octyl cyanoacrylate with a self-adhesive polymer mesh tape (2OPMT) and was compared to skin staples in spinal fusion surgery. The study involved 7204 patients that underwent spinal fusion surgery from a multicenter database. Their results showed that the 2OPMT group had a reduction in surgical time (240 vs 270 minutes), length of stay (3.35 vs 3.86 days), and SSI rates (1.11% vs 2.07%).[7] This system, combined with barbed sutures, was evaluated in a retrospective matched cohort study of 240 patients undergoing multilevel spinal fusion. Compared to conventional closure (interrupted sutures for fascia, polyglycolic acid for subcutaneous tissue, and staples for skin), it demonstrated reduced wound closure time with comparable wound-related complications at three-month follow-up.[14] Collectively, the available data on surgical tape use in spine surgery suggest that it provides comparable SSI rates to traditional methods. However, in the case of Yang et al., only small wounds were evaluated, and in the 2OPMT studies, although classified as a surgical tape, it combines the tape with a direct tissue adhesive applied to the wound, limiting comparability with our results. Studies on surgical tape use are more prevalent in other surgical fields, providing a basis for comparison with our results. Lazar et al. compared adhesive strips to subcuticular suture and skin sealant in a prospective randomized clinical trial in coronary artery bypass surgery. This study involved 26 patients who underwent both endoscopic and open harvesting of the saphenous vein, with a specific focus on wound closure for the vein harvesting incision. Patients in the adhesive strip group experienced less early post-surgery pain, exhibited a reduction in wound closure time, and similar wound-related complications.[15] In another prospective randomized clinical trial by Lazar et al., that included in the closure of a median sternotomy, adhesive strips were also the fastest method compared to sutures, with no increase in wound-related complications.[16] Other randomized clinical trials comparing sutures with adhesive strips have been conducted across diverse clinical scenarios, including episiotomy wound closure, thyroid/parathyroid surgery, and groin wound closure in pediatric patients. These studies demonstrated that adhesive strips are associated with reduced postoperative pain, cosmetic outcomes comparable to those achieved with subcuticular sutures, and similar rates of wound-related complications.[17–19] Two meta-analyses have evaluated the efficacy of adhesive strips in two different surgical settings. Luo et al. compared adhesive strips with surgical staples in total knee arthroplasty, reporting comparable wound-related complication rates while achieving reduced readmission rates in the adhesive strip group.[20] Similarly, a meta-analysis encompassing 18 randomized clinical trials in thyroid and parathyroid surgery reported that adhesive strips provided the fastest wound closure, with wound-related complications similar to those observed using skin staples and sutures.[21] While adhesive strips have generally shown favorable outcomes across various surgical fields, some studies have reported a higher incidence of wound complications, particularly related to bleeding and dehiscence. In the previously discussed study by Yang et al., one patient (3%) in the adhesive strip group experienced significant bleeding, necessitating wound evacuation and reapplication of adhesive tape.[13] Similar findings have been reported in abdominal surgery. In a randomized controlled trial of 90 patients comparing transcutaneous suturing, subcuticular sutures, and adhesive strips for closing laparoscopic port entry wounds, a higher incidence of wound dehiscence was observed in the adhesive strip group.[22] Another randomized clinical trial investigating the abdominal placement of subcutaneous hormone implants, compared adhesive strips against transcutaneous sutures in a cohort of 250 patients. The adhesive strips group experienced higher rates of bleeding compared to the suture group.[23] In both studies, SSI rates were comparable across groups, while rebleeding and dehiscence was higher in the adhesive strips group. Differences from the previously discussed studies may be due to the omission of subcutaneous closure, a step typically omitted in smaller incisions, such as those in minimally invasive surgery and minor procedures. Adhesive strips offer advantages over sutures, one of wich is their ability to minimize direct wound contact and prevent percutaneous bacterial entry. These factors may help reduce the inflammatory response in surgical wounds, as demonstrated in a rat model.[24] This could partially explain reports indicating improved cosmetic outcomes and lower SSI rates with the use of adhesive strips.[7,17] Another significant benefit is the reduction in surgical time, the importance of surgical time reduction was highlighted in a meta-analysis across various surgical specialties including general, orthopedic, colorectal, obstetric, and gynecologic procedures along with neurosurgical interventions such as craniotomies and ventriculoperitoneal shunt insertions. This analysis demonstrated a significant association between prolonged operative time and increased SSI risk, with infection likelihood rising by 13% for every additional 15 minutes of surgery.[25] Our pre-PSM data showed a nearly 15-minute reduction in operative time, which likely had minimal impact on our results. However, this factor may be more clinically significant in complex or extensive procedures, where prolonged wound closure further extends surgical duration. In summary, our results and existing literature supports adhesive strips as a viable method for wound closure in spinal fusion surgery when considering for correct tissue approximation, demonstrating comparable SSI rates and offering advantages over sutures and other methods like reduction of surgical time and length of stay. The primary limitations of our study arise from its retrospective design, which limited our ability to collect comprehensive data on key variables such as comorbidities, body mass index, and other established SSI risk factors. Additionally, wound-related complications such as bleeding and dehiscence were not assessed, restricting a more detailed comparison of closure methods. Moreover, the observed increase in mono-segmental surgeries during the later follow-up period may have introduced potential bias. Despite these limitations, our study adds to the growing body of evidence on alternative closure methods in spinal surgery and, to our knowledge, is the first to evaluate the use of adhesive strips in large lumbar wounds following spinal fusion. Our findings may have broader applicability to similar procedures, such as spinal decompression, which is commonly performed in the lumbar region but involves smaller surgical wounds. Conclusions Adhesive strips are non-inferior to sutures in SSI rates for one or two level lumbar spinal fusion. Declarations Author Contribution FANM: Data analysis, database handling, figure preparation, and writing of main manuscript, submission of final draft.CB: Data acquisition and database creation, critical revision of manuscript, equal contribution to first author.CT: Performed statistical analysis.EE: Image acquisition for figure 1 and critical revision of the manuscript.KV: Preparation of documentation for paper submission and critical revision of the manuscript.VK: Critical revision of the manuscript.MCOE: Critical revision of the manuscript.ES: Conception and study design, critical revision of the manuscripc, data interpretation, and project supervision.FV: Critical revision of the manuscript and project supervision.All authors reviewed the manuscript. 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BJOG Int J Obstet Gynaecol . 2002;109(10):1178-1180. doi:10.1111/j.1471-0528.2002.02015.x Sönmez K, Bahar B, Karabulut R, et al. Effects of different suture materials on wound healing and infection in subcutaneous closure techniques. B-ENT . 2009;5(3):149-152. Cheng H, Chen BPH, Soleas IM, Ferko NC, Cameron CG, Hinoul P. Prolonged Operative Duration Increases Risk of Surgical Site Infections: A Systematic Review. Surg Infect . 2017;18(6):722-735. doi:10.1089/sur.2017.089 Additional Declarations No competing interests reported. Supplementary Files dbstripsmatched.xlsx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Stuttgart","correspondingAuthor":false,"prefix":"","firstName":"Christian","middleName":"","lastName":"Bepperling","suffix":""},{"id":424294850,"identity":"e3829fd9-4ca5-43fa-8d49-d2ee419aa13b","order_by":2,"name":"Carlos Trenado","email":"","orcid":"","institution":"Heinrich Heine University Düsseldorf","correspondingAuthor":false,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Trenado","suffix":""},{"id":424294851,"identity":"25a3cc23-6f09-4103-b0a4-d19b2c485086","order_by":3,"name":"Steffen Eitelbuß","email":"","orcid":"","institution":"Diakonie-Klinikum Stuttgart","correspondingAuthor":false,"prefix":"","firstName":"Steffen","middleName":"","lastName":"Eitelbuß","suffix":""},{"id":424294852,"identity":"7ae9f956-3170-4a78-9d06-e2564f280b5f","order_by":4,"name":"Karen Velázquez","email":"","orcid":"","institution":"Diakonie-Klinikum 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Stuttgart","correspondingAuthor":false,"prefix":"","firstName":"Edgar","middleName":"","lastName":"Santos","suffix":""},{"id":424294856,"identity":"4bb5b304-5765-4ab2-b908-30d9d2a58a61","order_by":8,"name":"Farzam Vazifehdan","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA60lEQVRIiWNgGAWjYBAC9gYwZQPEjA0fGBuYQTwDvFp4DoCpNJCWxhmkaDkMIhiJ1MJ+9vGHnznnE/v7Dzc2fNxhLW/OwLzxAV4tPOkGhr3bbifOOHCwsXHmmXTDnQ1sxXitsQd6I4F3221jhoON7Y952w4zbjjAYyaB1xb+ZwwH/247Zyx/mLGx+W/bYXugFvMfeLVIpDE28247IGdwDKiFse1wIsgWfDqAWp4xM8tuS5YzPMPY2Njblp684TBbMQGHpTF/fLvNjkfu/PGHDT/brG03HG/e+AGvNZiAmUT1o2AUjIJRMAowAQBK/k+ea9PssAAAAABJRU5ErkJggg==","orcid":"","institution":"Diakonie-Klinikum Stuttgart","correspondingAuthor":true,"prefix":"","firstName":"Farzam","middleName":"","lastName":"Vazifehdan","suffix":""}],"badges":[],"createdAt":"2025-02-27 20:53:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6123787/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6123787/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":78241764,"identity":"2addc626-5d73-4a16-83f4-f837c3c688be","added_by":"auto","created_at":"2025-03-11 09:06:49","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1013641,"visible":true,"origin":"","legend":"\u003cp\u003eAdhesive strips application technique\u003cstrong\u003e. \u003c/strong\u003ea) Subdermal approximation of wound with interrupted suture of a wound of approximately 7 cm long, b) placement of adhesive strips in the surgical wound, c) surgical wound totally covered with adhesive strips, d) covering with 2nd layer of adhesive strips e) wound covered with gauze dressing for absorption of excess of blood and covered with a transparent dressing.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-6123787/v1/daea8c8aacbb854f24be57a0.png"},{"id":78241768,"identity":"e3c92fd2-031d-4694-b765-1c6142e930c8","added_by":"auto","created_at":"2025-03-11 09:06:49","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":166225,"visible":true,"origin":"","legend":"\u003cp\u003eForest plot of infection rates and absolute risk difference with non-inferiority margin. \u003cstrong\u003ea\u003c/strong\u003e. Infection rates for adhesive strips and sutures, with 95% CI. \u003cstrong\u003eb\u003c/strong\u003e. Absolute risk difference with its 95% CI. The dotted red line indicates the non-inferiority margin (δ = 0.03). The upper bound of the 95% CI for the absolute risk difference is below the margin of non-inferiority.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-6123787/v1/749d80605030d7b50a9d2e19.png"},{"id":78248606,"identity":"254bfaeb-5e15-41f4-a9a5-2e99184253f8","added_by":"auto","created_at":"2025-03-11 09:38:52","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2180967,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6123787/v1/a5a79ecb-ffed-4a2e-8b31-bab8e5758125.pdf"},{"id":78241761,"identity":"6d95466b-30e8-4570-a638-007f4a759d25","added_by":"auto","created_at":"2025-03-11 09:06:49","extension":"xlsx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":64706,"visible":true,"origin":"","legend":"","description":"","filename":"dbstripsmatched.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-6123787/v1/3a788e4d9a90538e9e6b0047.xlsx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Sutures vs. Adhesive Strips in Lumbar Spinal Fusion: Propensity-Matched Non-Inferiority Retrospective Analysis of Surgical Site Infections","fulltext":[{"header":"Introduction","content":"\u003cp\u003eSurgical site infections (SSIs) are among the most common complications in spine surgery, with a meta-analysis estimating an average SSI rate of approximately 2.7% in lumbar spine surgery.[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] For lumbar spinal fusion, the incidence ranges from 1.9\u0026ndash;4.48%, influenced by patient characteristics and risk factors.[\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] The selection of materials for skin closure in posterior spine surgery have been shown to impact the rates of SSI.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Currently sutures are the standard wound closure method in spine surgery, serving as the benchmark for comparison with other techniques. Emerging alternatives such as staples and tissue adhesives, have demonstrated advantages, including faster closure and shorter hospital stays, while maintaining comparable SSI rates.[\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eAmong emerging wound closure methods, adhesive strips (Omnistrip\u0026trade;; Hartmann, Sontheim, Germany), a type of adhesive tape, have undergone minimal evaluation, particularly for large wounds in spinal surgery. Our institution has utilized adhesive strips since 2017, with increased adoption during the COVID-19 pandemic to reduce patient-healthcare worker interaction. The observed benefits include shorter surgical duration, fewer postoperative visits, and improved cosmetic outcomes without an increase in wound-related complications led to their expanded use in larger wounds.\u003c/p\u003e \u003cp\u003eThis study aimed to compare SSI rates between sutures and adhesive strips in large surgical wounds, specifically in posterior one- and two-level open lumbar spinal fusion, using a non-inferiority analysis.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective single-center study employed propensity score matching (PSM) and non-inferiority analysis to compare sutures and adhesive strips for skin closure, with SSI rates as the primary outcome.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSettings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIt included patients who underwent one- or two-level lumbar spinal fusion via an open posterior approach at the Spine Center of Diakonie-Klinikum Stuttgart. Data were collected from 2019 to 2022 using the institution\u0026rsquo;s prospectively maintained database, which systematically tracks SSIs in treated patients. This study was approved by the ethic commission of the state medical association of Baden-W\u0026uuml;rttemberg (F-2024-077).\u003c/p\u003e\n\u003cp\u003ePostoperative follow-up was conducted through structured consultations to assess clinical status and wound healing. SSIs were diagnosed based on clinical signs of infection and confirmed by positive wound cultures, with severity classified according to the KISS surveillance protocol (A1: superficial, A2: deep, A3: organ/space). [8]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients included in the analysis underwent skin closure with either sutures (absorbable or non-absorbable) or adhesive strips and underwent open posterior spinal fusion of one or two segments. Exclusion criteria comprised patients under 18 years old, those with pre-existing surgical site infections (e.g., spondylodiscitis), surgeries other than open posterior spinal fusion, revision procedures for non-wound complications (e.g., pedicle screw or interbody cage fracture), infections classified as A3, endoscopic procedures, and surgeries involving more than two vertebral segments.\u003c/p\u003e\n\u003cp\u003eOnly SSIs occurring within 30 days post-surgery were analyzed, focusing exclusively on superficial infections, as deeper infections were unlikely to be influenced by the wound closure method.\u003c/p\u003e\n\u003cp\u003eThe surgical technique included fascial closure and subcutaneous tissue approximation, both performed using a standard interrupted suture technique with absorbable sutures in both groups. For skin closure, two methods were used: in the suture group, wounds were closed with either interrupted transcutaneous stitches using non-absorbable sutures or an absorbable subcuticular technique; in the adhesive strip group, wound edges were manually approximated before the sequential application of adhesive strips see figure 1.\u003c/p\u003e\n\u003cp\u003eSeven surgeons performed all closures, maintaining a consistent surgical technique throughout the study period. The use of adhesive strips increased gradually over time, with the same surgeons overseeing both wound closure and postoperative follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePropensity score matching\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data was analyzed before matching to obtain general insights and establish a baseline for comparison. To minimize selection bias in the final analysis, a PSM approach was applied. The propensity score was estimated using a logistic regression model, with the type of wound closure material as the dependent variable.\u003c/p\u003e\n\u003cp\u003eCovariates included gender, age, ASA classification, surgical time, use of drainage, and the number of surgical segments intervened. Nearest neighbor matching without replacement was performed using a caliper width of 0.2 times the standard deviation of the logit of the propensity score. After matching, all standardized mean differences (SMDs) were below 0.15, indicating an acceptable balance between groups: gender (SMD = 0.1092), age (SMD = 0.0007), surgical time (SMD = -0.1466), use of surgical drains (SMD = 0.1244), and number of segments (SMD = -0.0667).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll statistical analyses and graphical representations were conducted using IBM SPSS Statistics Version 25 (RRID:SCR_002865), R (RRID:SCR_001905), and Matlab Version 9.12 (RRID:SCR_001622). Frequencies and proportions were calculated, along with their 95% confidence intervals (CI). To assess normality of quantitative data a Shapiro-Wilk test was performed. Based on the results, an independent t-test was employed for normally distributed data, while a Mann-Whitney U test was conducted for non-parametric distributions. Chi-square test was employed for the analysis of categorical data, for ordinal data a Cochran-Armitage test for trend was employed. The null hypothesis was rejected if the p-value was less than 0.05.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNon-inferiority margin\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNon-inferiority was assessed using a Wald test with a 3% non-inferiority margin. The null hypothesis was rejected if the upper bound of the 95% one-sided confidence interval for the absolute risk difference remained below this threshold. This 3% margin is considered conservative in the context of wound infections, as previous studies have adopted wider margins of up to 10%.[9\u0026ndash;12] \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eH\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003eo\u003c/sub\u003e\u003c/strong\u003e\u003cstrong\u003e: p\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003e1\u003c/sub\u003e\u003c/strong\u003e\u003cstrong\u003e-p\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003e2\u003c/sub\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026ge; \u0026delta;\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp; \u003cstrong\u003e\u0026nbsp;p1\u003c/strong\u003e: Adhesive strips group rate of SSIs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHa: p\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003e1\u003c/sub\u003e\u003c/strong\u003e\u003cstrong\u003e-p\u003c/strong\u003e\u003cstrong\u003e\u003csub\u003e2\u003c/sub\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u0026le;\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e\u0026delta;\u003c/strong\u003e \u003cstrong\u003e\u0026nbsp;p2:\u003c/strong\u003e Suture group rate of SSIs\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026delta;=0.03\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 1016 patients were identified over a four-year period, with an overall infection rate of 2.84% (A1, A2 and A3). Patients diagnosed with A3 infections (13 patients) were excluded from the analysis, as it was assumed that the presence of these infections were not affected by the wound closure techniques being evaluated.\u003c/p\u003e\n\u003cp\u003eFrom the resulting 1003 patient records six more patients were eliminated from the analysis due to lack of complete data. Finally, 997 patients were included in the analysis in which 346 (34%) patients were treated with suture and 651 with adhesive strips (65%).\u003c/p\u003e\n\u003cp\u003eBaseline characteristics of the population are described in table 1. In summary, there was statistical difference in gender distribution (p 0.029), surgical time (p\u0026lt;0.001), hospital stay (p\u0026lt;0.001), ASA score (p\u0026lt;0.001) and utilization of surgical drains (p\u0026lt;0.001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u003c/strong\u003e. Demographic and surgical characteristics before propensity score matching. \u003cstrong\u003eASA\u003c/strong\u003e, American Society of Anesthesiologists Physical Status Classification System,\u003cstrong\u003e\u0026nbsp;SD\u003c/strong\u003e, Standard Deviation, \u003cstrong\u003ea,\u0026nbsp;\u003c/strong\u003esurgical time is expressed in minutes, \u003cstrong\u003eb,\u0026nbsp;\u003c/strong\u003eLength of stay is expressed in days, statistically significant difference (*).\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"512\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;Patients characteristics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSuture\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdhesive strips\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eAge (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e66.9(13.11)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e66.9(13.26)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e0.27\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eGender (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e0.029*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e244(70.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e413(63.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e102(29.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e238(36.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eSurgical time \u003csup\u003ea\u003c/sup\u003e (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e132.2 (43.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e116.2(40.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e2.34E-08*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eLength of stay \u003csup\u003eb\u003c/sup\u003e (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e8.8 (5.03)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e7.5(5.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e2.31E-20*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eSegments (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e0.065\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e233(67.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e476(73.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e113(32.65)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e175(26.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eUse of surgical drains (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e1.01E-16*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e175(50.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e499(76.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e171(49.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e152(23.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eASA (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e2.01E-05*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e15(4.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e13(1.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e237(68.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e380(58.37)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e94(27.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e257(39.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e1(0.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 182px;\"\u003e\n \u003cp\u003eVI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 126px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 128px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eTo control differences in the cohort a PSM was performed. The matching process excluded 347 patients from the adhesive strips group and 42 patients from the sutures group. The final cohorts consisted of 304 patients in each group with differences balanced \u0026nbsp;with the exception of length of stay (p\u0026lt;0.001). The characteristics of the matched cohort are shown in table 2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e Demographics and surgical characteristics after propensity score matching. \u003cstrong\u003eASA\u003c/strong\u003e, American Society of Anesthesiologists Physical Status Classification System,\u003cstrong\u003e\u0026nbsp;SD\u003c/strong\u003e, Standard Deviation, \u003cstrong\u003ea,\u0026nbsp;\u003c/strong\u003esurgical time is expressed in minutes, \u003cstrong\u003eb,\u0026nbsp;\u003c/strong\u003eLength of stay is expressed in days, statistically significant difference (*).\u003c/p\u003e\n\u003cdiv align=\"\"\u003e\n \u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"472\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003ePatients characteristics\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSutures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAdhesive strips\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eAge (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e66.9(13.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e66.9(13.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.906\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eGender (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.198\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e209(68.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e193(63.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e95(31.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e111(36.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eSurgical time \u003csup\u003ea\u003c/sup\u003e (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e127.1(41.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e121.2(43.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.065\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eLength of stay \u003csup\u003eb\u003c/sup\u003e (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e8.8(5.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e7.2(4.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e7.92673e-16*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eSegments (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.467\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e216(71.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e225(74.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e88(28.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e79(25.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eUse of surgical drains (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.213\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e175(57.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e191(62.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e129(42.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e113(37.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eASA (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e0.579\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e11(3.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e7(2.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e199(65.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e200(65.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e94(30.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e97(31.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 160px;\"\u003e\n \u003cp\u003eVI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 101px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 117px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eSSIs rate and non-inferiority.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter PSM SSI rates were 1.64% (95% CI: 0.70 \u0026ndash; 3.79%) for sutures and 1.97% (95% CI: 0.91 \u0026ndash; 4.24%) for adhesive strips (Figure 2). The one-sided Wald test using a 3% non-inferiority margin yielded a risk difference of 0.33% (SE = 1.1%), with z = \u0026ndash;2.47 and a one-sided p-value of 0.0067. The upper bound of the 95% one-sided confidence interval for the absolute risk difference was 2.11%, below the 3% margin.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe results of this study supports the use of adhesive strips as a comparable alternative to sutures for wound closure in open posterior one- and two-level lumbar spinal fusion, with similar SSI rates. Statistical analysis demonstrated a 0.33% difference in SSI rates, establishing non-inferiority within a 3% absolute risk difference margin.\u003c/p\u003e\n\u003cp\u003eThe comparable SSI rates between adhesive strips and sutures in our data are consistent with findings from other studies. Yang et al. conducted a small retrospective study of 36 patients who underwent percutaneous vertebroplasty with 1.5\u0026ndash;2 cm incisions to assess wound complications. Adhesive tapes were used in 91.6% of cases, while 8.3% received sutures. No SSIs were observed in either group, and complications occurred in only one patient in the adhesive tape group, related to bleeding.[13] A larger retrospective study sponsored by Ethicon employing a similar method investigated the Dermabond Prineo-Skin Closure System (Ethicon Inc., NJ, USA). This system integrates 2‑octyl cyanoacrylate with a self-adhesive polymer mesh tape (2OPMT) and was compared to skin staples in spinal fusion surgery.\u003csup\u003e\u0026nbsp;\u003c/sup\u003e The study involved 7204 patients that underwent spinal fusion surgery from a multicenter database. Their results showed that the 2OPMT group had a reduction in surgical time (240 vs 270 minutes), length of stay (3.35 vs 3.86 days), and SSI rates (1.11% vs 2.07%).[7]\u0026nbsp;This system, combined with barbed sutures, was evaluated in a retrospective matched cohort study of 240 patients undergoing multilevel spinal fusion. Compared to conventional closure (interrupted sutures for fascia, polyglycolic acid for subcutaneous tissue, and staples for skin), it demonstrated reduced wound closure time with comparable wound-related complications at three-month follow-up.[14]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCollectively, the available data on surgical tape use in spine surgery suggest that it provides comparable SSI rates to traditional methods. However, in the case of Yang et al., only small wounds were evaluated, and in the 2OPMT studies, although classified as a surgical tape, it combines the tape with a direct tissue adhesive applied to the wound, limiting comparability with our results.\u003c/p\u003e\n\u003cp\u003eStudies on surgical tape use are more prevalent in other surgical fields, providing a basis for comparison with our results. Lazar et al. compared adhesive strips to subcuticular suture and skin sealant in a prospective randomized clinical trial in coronary artery bypass surgery. This study involved 26 patients who underwent both endoscopic and open harvesting of the saphenous vein, with a specific focus on wound closure for the vein harvesting incision. Patients in the adhesive strip group experienced less early post-surgery pain, exhibited a reduction in wound closure time, and similar wound-related complications.[15] In another prospective randomized clinical trial by Lazar et al., that included in the closure of a median sternotomy, adhesive strips were also the fastest method compared to sutures, with no increase in wound-related complications.[16] Other randomized clinical trials comparing sutures with adhesive strips have been conducted across diverse clinical scenarios, including episiotomy wound closure, thyroid/parathyroid surgery, and groin wound closure in pediatric patients. These studies demonstrated that adhesive strips are associated with reduced postoperative pain, cosmetic outcomes comparable to those achieved with subcuticular sutures, and similar rates of wound-related complications.[17\u0026ndash;19]\u003c/p\u003e\n\u003cp\u003eTwo meta-analyses have evaluated the efficacy of adhesive strips in two different surgical settings. Luo et al. compared adhesive strips with surgical staples in total knee arthroplasty, reporting comparable wound-related complication rates while achieving reduced readmission rates in the adhesive strip group.[20] Similarly, a meta-analysis encompassing 18 randomized clinical trials in thyroid and parathyroid surgery reported that adhesive strips provided the fastest wound closure, with wound-related complications similar to those observed using skin staples and sutures.[21]\u003c/p\u003e\n\u003cp\u003eWhile adhesive strips have generally shown favorable outcomes across various surgical fields, some studies have reported a higher incidence of wound complications, particularly related to bleeding and dehiscence. In the previously discussed study by Yang et al., one patient (3%) in the adhesive strip group experienced significant bleeding, necessitating wound evacuation and reapplication of adhesive tape.[13] Similar findings have been reported in abdominal surgery. In a randomized controlled trial of 90 patients comparing transcutaneous suturing, subcuticular sutures, and adhesive strips for closing laparoscopic port entry wounds, a higher incidence of wound dehiscence was observed in the adhesive strip group.[22] Another randomized clinical trial investigating the abdominal placement of subcutaneous hormone implants, compared adhesive strips against transcutaneous sutures in a cohort of 250 patients. The adhesive strips group experienced higher rates of bleeding compared to the suture group.[23] \u0026nbsp;In both studies, SSI rates were comparable across groups, while rebleeding and dehiscence was higher in the adhesive strips group. Differences from the previously discussed studies may be due to the omission of subcutaneous closure, a step typically omitted in smaller incisions, such as those in minimally invasive surgery and minor procedures.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdhesive strips offer advantages over sutures, one of wich is their ability to minimize direct wound contact and prevent percutaneous bacterial entry. These factors may help reduce the inflammatory response in surgical wounds, as demonstrated in a rat model.[24] This could partially explain reports indicating improved cosmetic outcomes and lower SSI rates with the use of adhesive strips.[7,17]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAnother significant benefit is the reduction in surgical time, the importance of surgical time reduction was highlighted in a meta-analysis across various surgical specialties including general, orthopedic, colorectal, obstetric, and gynecologic procedures along with neurosurgical interventions such as craniotomies and ventriculoperitoneal shunt insertions. This analysis demonstrated a significant association between prolonged operative time and increased SSI risk, with infection likelihood rising by 13% for every additional 15 minutes of surgery.[25] \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur pre-PSM data showed a nearly 15-minute reduction in operative time, which likely had minimal impact on our results. However, this factor may be more clinically significant in complex or extensive procedures, where prolonged wound closure further extends surgical duration.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn summary, our results and existing literature supports adhesive strips as a viable method for wound closure in spinal fusion surgery when considering for correct tissue approximation, demonstrating comparable SSI rates and offering advantages over sutures and other methods like reduction of surgical time and length of stay.\u003c/p\u003e\n\u003cp\u003eThe primary limitations of our study arise from its retrospective design, which limited our ability to collect comprehensive data on key variables such as comorbidities, body mass index, and other established SSI risk factors. Additionally, wound-related complications such as bleeding and dehiscence were not assessed, restricting a more detailed comparison of closure methods. Moreover, the observed increase in mono-segmental surgeries during the later follow-up period may have introduced potential bias.\u003c/p\u003e\n\u003cp\u003eDespite these limitations, our study adds to the growing body of evidence on alternative closure methods in spinal surgery and, to our knowledge, is the first to evaluate the use of adhesive strips in large lumbar wounds following spinal fusion.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur findings may have broader applicability to similar procedures, such as spinal decompression, which is commonly performed in the lumbar region but involves smaller surgical wounds.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eAdhesive strips are non-inferior to sutures in SSI rates for one or two level lumbar spinal fusion.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\n\u003cp\u003eFANM: Data analysis, database handling, figure preparation, and writing of main manuscript, submission of final draft.CB: Data acquisition and database creation, critical revision of manuscript, equal contribution to first author.CT: Performed statistical analysis.EE: Image acquisition for figure 1 and critical revision of the manuscript.KV: Preparation of documentation for paper submission and critical revision of the manuscript.VK: Critical revision of the manuscript.MCOE: Critical revision of the manuscript.ES: Conception and study design, critical revision of the manuscripc, data interpretation, and project supervision.FV: Critical revision of the manuscript and project supervision.All authors reviewed the manuscript.\u003c/p\u003e\n\u003ch2\u003eData Availability\u003c/h2\u003e\n\u003cp\u003eData is provided within the manuscript or supplementary information files\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eZhou J, Wang R, Huo X, Xiong W, Kang L, Xue Y. Incidence of Surgical Site Infection After Spine Surgery: A Systematic Review and Meta-analysis. \u003cem\u003eSpine\u003c/em\u003e. 2020;45(3):208-216. doi:10.1097/BRS.0000000000003218\u003c/li\u003e\n\u003cli\u003eLi Z, Liu P, Zhang C, et al. Incidence, Prevalence, and Analysis of Risk Factors for Surgical Site Infection After Lumbar Fusion Surgery: \u0026ge;2-Year Follow-Up Retrospective Study. \u003cem\u003eWorld Neurosurg\u003c/em\u003e. 2019;131:e460-e467. doi:10.1016/j.wneu.2019.07.207\u003c/li\u003e\n\u003cli\u003eRao SB, Vasquez G, Harrop J, et al. Risk Factors for Surgical Site Infections Following Spinal Fusion Procedures: A Case-Control Study. \u003cem\u003eClin Infect Dis\u003c/em\u003e. 2011;53(7):686-692. doi:10.1093/cid/cir506\u003c/li\u003e\n\u003cli\u003eRudic TN, Althoff AD, Kamalapathy P, Bachmann KR. Surgical Site Infection After Primary Spinal Fusion Surgery for Adolescent Idiopathic Scoliosis: An Analysis of Risk Factors From a Nationwide Insurance Database. \u003cem\u003eSpine\u003c/em\u003e. 2023;48(8):E101-E106. doi:10.1097/BRS.0000000000004591\u003c/li\u003e\n\u003cli\u003eMolliqaj G, Lener S, Da Broi M, et al. Risk of Surgical Site Infection in Posterior Spine Surgery Using Different Closing Techniques: A Retrospective Study of Two Neurosurgical Centers. \u003cem\u003eJ Clin Med\u003c/em\u003e. 2024;13(24):7675. doi:10.3390/jcm13247675\u003c/li\u003e\n\u003cli\u003eAndo M, Tamaki T, Yoshida M, et al. Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. \u003cem\u003eEur Spine J\u003c/em\u003e. 2014;23(4):854-862. doi:10.1007/s00586-014-3202-5\u003c/li\u003e\n\u003cli\u003eJohnston SS, Fortin SP, Pracyk JB, Tommaselli GA, Elangovanraaj N, Chen BP. Economic and clinical outcomes of spinal fusion surgeries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape. \u003cem\u003eSpine J\u003c/em\u003e. 2021;21(1):45-54. doi:10.1016/j.spinee.2020.08.017\u003c/li\u003e\n\u003cli\u003ePetra Gastmeier. \u003cem\u003eNationales Referenzzentrum f\u0026uuml;r Surveillance von nosokomialen Infektionen\u003c/em\u003e. Nationales Referenzzentrum f\u0026uuml;r Surveillance von nosokomialen Infektionen (NRZ); 2020:62. https://www.nrz-hygiene.de/files/Protokolle/OP-Protokolle/Wundinfektionen/OP_KISS_Protokoll_WI_v202011.pdf\u003c/li\u003e\n\u003cli\u003eGarrig\u0026oacute;s C, Rosso-Fern\u0026aacute;ndez CM, Borreguero I, et al. Efficacy and safety of different antimicrobial DURATions for the treatment of Infections associated with Osteosynthesis Material implanted after long bone fractures (DURATIOM): Protocol for a randomized, pragmatic trial. \u003cem\u003ePLOS ONE\u003c/em\u003e. 2023;18(5):e0286094. doi:10.1371/journal.pone.0286094\u003c/li\u003e\n\u003cli\u003eU\u0026ccedil;kay I, Wirth S, Z\u0026ouml;rner B, et al. Study protocol: short against long antibiotic therapy for infected orthopedic sites \u0026mdash; the randomized-controlled SALATIO trials. \u003cem\u003eTrials\u003c/em\u003e. 2023;24(1):117. doi:10.1186/s13063-023-07141-2\u003c/li\u003e\n\u003cli\u003eVissers FL, Balduzzi A, Van Bodegraven EA, et al. Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a study protocol of a binational multicenter randomized controlled trial. \u003cem\u003eTrials\u003c/em\u003e. 2022;23(1):809. doi:10.1186/s13063-022-06736-5\u003c/li\u003e\n\u003cli\u003eDelgado-L\u0026oacute;pez PD, Mart\u0026iacute;n-Alonso J, Herrero-Guti\u0026eacute;rrez AI, et al. Barbed versus conventional suture in elective posterior spine surgery. \u003cem\u003eEur Spine J\u003c/em\u003e. 2024;33(6):2261-2268. doi:10.1007/s00586-024-08224-7\u003c/li\u003e\n\u003cli\u003eYang C, Qiu T, Chee Cheong RS, Ou Yang Y. Skin Adhesive Tapes: An Effective Wound Closure Method for Percutaneous Vertebral Body Stenting. \u003cem\u003eCureus\u003c/em\u003e. Published online August 26, 2024. doi:10.7759/cureus.67859\u003c/li\u003e\n\u003cli\u003eMun J, Hyun SJ, Lee JK, An S, Kim KJ. Surgical and Clinical Outcomes Associated With the Use of Barbed Sutures and Self-Adhering Mesh System and Polymeric Glue for Wound Closure in Multilevel or Revision Spinal Surgery: A Matched Cohort Comparative Study With Conventional Wound Closure Procedure. \u003cem\u003eNeurospine\u003c/em\u003e. 2023;20(3):981-988. doi:10.14245/ns.2346534.267\u003c/li\u003e\n\u003cli\u003eLazar HL, McCann J, Fitzgerald CA, Thompson J, Bao Y, Cabral HJ. Novel Adhesive Skin Closures Improve Wound Healing Following Saphenous Vein Harvesting. \u003cem\u003eJ Card Surg\u003c/em\u003e. 2008;23(2):152-155. doi:10.1111/j.1540-8191.2007.00563.x\u003c/li\u003e\n\u003cli\u003eLazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive Strips Versus Subcuticular Suture for Mediansternotomy Wound Closure. \u003cem\u003eJ Card Surg\u003c/em\u003e. 2011;26(4):344-347. doi:10.1111/j.1540-8191.2011.01257.x\u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Leary DP, Clover AJ, Galbraith JG, Mushtaq M, Shafiq A, Redmond HP. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: A prospective, randomized controlled trial. \u003cem\u003eSurgery\u003c/em\u003e. 2013;153(3):408-412. doi:10.1016/j.surg.2012.08.063\u003c/li\u003e\n\u003cli\u003eLadipo-Ajayi OA, Lawal TA, Ogundoyin OO, Michael AI. Steri-Strip\u003csup\u003eTM\u003c/sup\u003e versus Subcuticular Skin Closure of Paediatric Groin Wounds: A Randomised Study. \u003cem\u003eAfr J Paediatr Surg\u003c/em\u003e. 2022;19(3):137-143. doi:10.4103/ajps.AJPS_184_20\u003c/li\u003e\n\u003cli\u003eSherif A, El-Shourbagy M. Skin-Adhesive Tape versus Interrupted Suture in Episiotomy Skin Repair: Randomized Control Trial. \u003cem\u003eOpen J Obstet Gynecol\u003c/em\u003e. 2020;10(02):254-263. doi:10.4236/ojog.2020.1020022\u003c/li\u003e\n\u003cli\u003eLuo X, Zhang W, Yan P, et al. Skin Closure Tape and Surgical Staples in Primary Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. \u003cem\u003eBioMed Res Int\u003c/em\u003e. 2020;2020(1):4827617. doi:10.1155/2020/4827617\u003c/li\u003e\n\u003cli\u003ePerivoliotis K, Christodoulou P, Liapis S, Ziamas D, Ntentas I, Lytras D. Comparison of wound closure techniques after thyroid and parathyroid surgery: an updated systematic review and network meta-analysis. \u003cem\u003eUpdat Surg\u003c/em\u003e. 2022;74(4):1225-1237. doi:10.1007/s13304-022-01296-4\u003c/li\u003e\n\u003cli\u003eSingh PK, Das Poddar KK, Sasmal PK, Kumar P, Ali SM, Mishra TS. Comparison of laparoscopic port site skin closure techniques (CLOSA): transcutaneous suturing versus subcuticular sutures versus adhesive strips: a prospective single-blinded randomized control trial. \u003cem\u003eLangenbecks Arch Surg\u003c/em\u003e. 2023;408(1):228. doi:10.1007/s00423-023-02950-0\u003c/li\u003e\n\u003cli\u003eSelo‐Ojeme DO, Lim KB. Randomised clinical trial of suture compared with adhesive strip for skin closure after HRT implant. \u003cem\u003eBJOG Int J Obstet Gynaecol\u003c/em\u003e. 2002;109(10):1178-1180. doi:10.1111/j.1471-0528.2002.02015.x\u003c/li\u003e\n\u003cli\u003eS\u0026ouml;nmez K, Bahar B, Karabulut R, et al. Effects of different suture materials on wound healing and infection in subcutaneous closure techniques. \u003cem\u003eB-ENT\u003c/em\u003e. 2009;5(3):149-152.\u003c/li\u003e\n\u003cli\u003eCheng H, Chen BPH, Soleas IM, Ferko NC, Cameron CG, Hinoul P. Prolonged Operative Duration Increases Risk of Surgical Site Infections: A Systematic Review. \u003cem\u003eSurg Infect\u003c/em\u003e. 2017;18(6):722-735. doi:10.1089/sur.2017.089\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Lumbar Spinal Fusion; Surgical Site Infections, Adhesive Strips, Adhesive Tape, Spine Surgery, Non-inferiority Study, Spondylodesis","lastPublishedDoi":"10.21203/rs.3.rs-6123787/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6123787/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e: To compare surgical site infection rates between adhesive strips and sutures in lumbar spinal fusion surgery, using a non-inferiority margin.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e:\u003c/p\u003e\n\u003cp\u003eThis single-center retrospective study compared surgical site infection (SSI) rates between sutures and adhesive strips in lumbar spinal fusion using propensity score matching (PSM) and a 3% non-inferiority margin. Patients undergoing one- or two-level lumbar fusion via an open posterior approach between 2019 and 2022 were included. Data were extracted from a prospectively maintained database, and postoperative SSIs were classified using the KISS surveillance system. Exclusion criteria included patients under 18, pre-existing infections, revision surgeries, and deep organ/space infections. PSM balanced covariates such as age, gender, ASA classification, surgical time, use of drainage, and the number of levels fused. A total of 997 patient records were analyzed. After applying PSM, 608 patients were evenly divided into two groups. Statistical analysis included t-tests, Mann-Whitney U tests, chi-square tests, and a Wald test for non-inferiority, rejecting the null hypothesis if the 95% one-sided confidence interval remained below the 3% margin.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Following PSM, infection rates were 1.64% for sutures and 1.97% for adhesive strips. A one-sided Wald test with a 3% non-inferiority margin produced an absolute risk difference of 0.33% (SE 1.1%; z = –2.47; one-sided p = 0.0067) and an upper 95% CI bound of 2.11%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: Adhesive strips are non-inferior to sutures in SSI rates for one or two level lumbar spinal fusion.\u003c/p\u003e\n\u003cp\u003eRegistered at ClinicalTrials.gov Identifier NCT06664424 on October 15, 2024.\u003c/p\u003e","manuscriptTitle":"Sutures vs. Adhesive Strips in Lumbar Spinal Fusion: Propensity-Matched Non-Inferiority Retrospective Analysis of Surgical Site Infections","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-11 09:06:44","doi":"10.21203/rs.3.rs-6123787/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f8346c60-cd0a-4396-aa75-34b6c8a7cef8","owner":[],"postedDate":"March 11th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-03-11T09:06:47+00:00","versionOfRecord":[],"versionCreatedAt":"2025-03-11 09:06:44","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6123787","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6123787","identity":"rs-6123787","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}