Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial

Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial | 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 Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial Alexander Romagna, Jens Lehmberg, Michael Meier, Michael Stelzer, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4512742/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 13 Aug, 2024 Read the published version in Acta Neurochirurgica → Version 1 posted 9 You are reading this latest preprint version Abstract Purpose Superficial surgical site infection (SSSI) is a prominent problem in spine surgery. Intracutaneous sutures and staple-assisted closure are two widely used surgical techniques for skin closure. Yet, their comparative impact on wound healing and infection rates is underexplored. Our goal was to address this gap and compare wound healing between these two techniques. Methods This study was a multicenter international prospective randomized trial. Patient data were prospectively collected at three large academic centers, patients who underwent non-instrumented lumbar primary spine surgery were included. Patients were intraoperatively randomized to either intracutaneous suture or staple-assisted closure cohorts. The primary endpoint was SSSI within 30 days after surgery according to the wound infection Centers for Disease Control and Prevention (CDC) classification system. Results Of 207 patients, 110 were randomized to intracutaneous sutures and 97 to staple-assisted closure. Both groups were homogenous with respect to epidemiological as well as surgical parameters. Two patients (one of each group) suffered from an A1 wound infection at the 30-day follow up. Median skin closure time was faster in the staple-assisted closure group (198 seconds vs. 13 seconds, p < 0,001). Conclusion This study showed an overall low superficial surgical site infection rate in both patient cohorts in primary non instrumented spine surgery. Intracutaneous suture lumbar spine surgery staples superficial surgical site infection wound healing Figures Figure 1 Figure 2 Figure 3 Introduction Postoperative wound infections following spine surgery occur at a frequency of 1–6% [ 1 – 3 ]. Although this rate might appear small, it is a persistent cause of elevated morbidity and treatment costs in modern day spine surgery. While there are some surgeon-independent factors influencing this problem, the process of skin closing is commonly determined by the surgeon and/or departmental preferences [ 4 ]. Among various options, the decision between using intracutaneous sutures versus staple-assisted wound closure is of particular interest because both techniques are widely used. Each technique has its own potential advantages: while intracutaneous sutures are believed to create an internal barrier against potential contaminants, staple-assisted closure may offer a time advantage and superior ease of use [ 5 , 6 ]. In elective gastrointestinal surgery, a large prospective randomized study comparing both techniques failed to demonstrate a lower rate of superficial wound infections in intracutaneous suturing compared to staple-assisted closure but less wound dehiscence in the former [ 4 ]. Although there has been a substantial increase in evidence on wound closure techniques in spine surgery, most data are hampered by their retrospective, monocentric and heterogenous nature [ 5 – 7 ]. Obtaining an improved understanding of which wound closure is superior has the potential to guide surgical decision-making. In this study, we prospectively compared the randomized use of intracutaneous sutures and staple-assisted closure after lumbar spine surgery in a multicentric cohort. Methods Study design and patients This study is a multicenter prospective randomized trial of patients undergoing non-instrumented lumbar primary spine surgery. Patient recruitment was performed at three Central European centers. In one study cohort the skin was closed with a single-use skin stapler with stainless steel staples (Covidien, Mansfield, MA) and in the other study cohort the skin was closed intracutaneously with absorbable sutures (either Monosyn®, B. Braun Surgical SA, Rubí, Spain or V-Loc™ wound closure device, Covidien, Mansfield, MA). All ethics committees reviewed the study protocol (approval numbers 785/20 S-SR and 1094/2021). We included patients who were about to undergo non-instrumented primary surgery at the lumbar spine and the thoracolumbar junction via a posterior midline approach. These procedures comprised uni- or multilevel microscopic decompression of the spinal canal for spinal canal stenosis or disc herniation. Patients with prior surgery at the same or at an adjacent level, prior antibiotic treatment (within two weeks prior to surgery) or patients who were planned to receive any type of instrumentation were excluded. Cephalosporins were most commonly used for perioperative antimicrobial prophylaxis to prevent surgical site infection. The primary endpoint of the study was the occurrence of an A1 SSSI (skin/subcutaneous tissue) as described in the CDC classification system for surgical site infections within 30 days after the procedure [ 8 ]. Secondary endpoints were perioperative data i.e. blood loss, cerebrospinal fluid (CSF) leaks and the duration of skin closure. Study protocol Participating patients were randomized to the intracutaneous suture or staple-assisted closure by alternation coordinated by each study center. All patients’ gave written informed consent to the scheduled surgical procedure and study participation; no patients were lost or retracted their participation agreement after study inclusion and randomization. The lead surgeon was informed shortly before skin closure. Patients were then followed-up on the 6th and 30th day by the study doctors and the study nurse and results were documented photographically and on a multicentrally used follow-up sheet. Skin staples were usually removed on the 7th to 10th postoperative day while absorbable intracutaneous sutures did not require any removal. In case of re-operation the patient was excluded from further follow-up. Statistical analysis The study cohort was characterized using means and standard deviations to describe continuous variables and proportions to describe categorical variables. Outcome data analysis was performed as per protocol. Primary endpoint analysis was planned using descriptive statistics. Secondary endpoints and perioperative patient data were analyzed by exploratory descriptive analysis as well as using the Wilcoxon-Mann-Whitney test to detect differences between the groups. A p-value below 0.05 was used as criterion for statistically significant difference throughout all analyses. All statistical calculations were performed with R and SPSS Statistics. Results During the study period from May 2021 to July 2023, a total of 207 patients were randomized and included in the analysis. Ninety-seven (46.9%) patients were randomized to the intracutaneous suture group, and 110 (53.1%) patients to the staple-assisted closure cohort; the study population was homogeneous for assessed patient characteristics (p > 0.05) (Table 1 ). No differences in age (p = 0.857) and sex (p = 0,737) distributions was seen between participating centers. Skin closure times stratified by surgical techniques of all centers are displayed in Fig. 1 . An A1 SSSI within 30 days after surgery was found in two cases only (one in each cohort; illustrative case in Fig. 2 ). Both patients were smokers and one of them additionally suffered from diabetes type II. Both infections healed without any additional surgical treatment and without causing any disabling long-term sequelae. No A2 and A3 wound infections as defined by the CDC classification system for surgical site infections were observed. Maximum missing values were 26 for the total variable “median lumbar subcutaneous fat tissue thickness” as shown in Table 1 . Intraoperative data, including metrics such as duration of surgery, length of incision as well as the location and the extent of operated levels, were evenly distributed between the two groups and across all three participating centers (Table 2 ; maximum missing values were 45 for the total variable “length of incision”). The same was found for blood loss and incidences of CSF leaks. The duration of skin closure was on average longer in the intracutaneous suture group (198 seconds) compared to the staple-assisted closure group (13 seconds, U = 147, p < 0.001; Table 2 and Fig. 1 ). This was independent from the length of the incision (shown in Fig. 3 ) but did not influence the overall median surgical time (intracutaneous suture group 73 minutes vs. staple-assisted closure group 78 minutes, U = 4493 p = 0.238). Thirty-one (15%) patients were lost to follow up due to various reasons including travel distance, non-compliance and in the first period the COVID-19 lockdown. All data that support the findings of this study are available from the corresponding author upon reasonable request. Table 1 Basic population characteristics. All patients n = 207 Intracutaneous suture group n = 97 Staple-assisted closure group n = 110 Median Age (years) (IQR) 57.4 (42-72.5) 57.7 (42–73) 57.2 (42.3–69.6) Sex male female 122 (58.9%) 85 (41.1%) 59 (60.8%) 38 (39.2%) 63 (57.3%) 47 (42.7%) Median body mass index (IQR) 25.1 (24-29.2) 24.3 (24-29.1) 25.8 (24-29.2) Median American Society of Anesthesiologists Score (IQR) 2 (2–3) 2 (2–3) 2 (2–3) Median lumbar subcutaneous fat tissue thickness (mm) (IQR) 23 (15–33) 23 (14-33.5) 23 (17–30) Diabetes yes total 29 (14%) 18 (18.6%) 11 (10%) Steroid treatment total 5 (2.4%) 2 (2.1%) 3 (2.7%) Nicotine abusus total 82 (39.6%) 38 (39.2%) 44 (40%) No significant differences between treatment groups for all evaluated parameters were detected (p > 0.05). Table 2 Surgery characteristics Total Intracutaneous suture group Staple-assisted closure group Median surgery duration in min* (IQR) 75 (58.8–100) 73 (59–90) 78 (58.5–103) Median incision length in mm (IQR) 40 (35–50) 40 (35–50) 40 (35–50) Lumbar location Monosegemental Bisegmental Trisegmental 203 (98.1%) 170 (82.1%) 27 (13%) 6 (2.9%) 94 (96.9%) 84 (86.6%) 9 (9.3%) 1 (1%) 109 (99.1%) 86 (78.2%) 18 (16.4%) 5 (4.5%) Use of redon drain total 75 (36.2%) 32 (33%) 43 (39.1%) Median Blood loss (ml) (IQR) 156 (10–600) 118 (10–600) 187 (30–500) Cerebrospinal fluid leaks total 16 (7.7%) 8 (8.2%) 8 (7.3%) * Significant difference between treatment groups (p < 0.001) Discussion Superficial surgical site infections are a significant concern in spine surgery due to their potential sequelae [ 9 , 10 ]. This study aimed to address this concern by comparing the impact of two commonly used skin closure techniques, intracutaneous sutures and staple-assisted closure, on wound healing and infection rates in non-instrumented primary spine surgery [ 7 , 11 ]. Our study’s main finding were i) the rate of infections was generally low in both cohorts and independent of the applied skin closure technique, and ii) closure with staples was the faster option which, however, did not significantly impact the total operating time. Superficial site infections have been a persistent issue in all surgical fields [ 12 ]. Previous research comparing these two specific techniques in elective gastrointestinal surgery did not find a lower rate of superficial wound infections in intracutaneous suturing compared to staple-assisted closure but did identify less wound dehiscence in the former [ 4 ]. In contrast, the available literature concerning wound closure methods in spine surgery is mostly retrospective, monocentric and heterogeneous by including instrumented fusion procedures as well as revision surgeries [ 5 – 7 , 13 ]. For instance, a systematic review by Yilmaz et al. on posterior spinal fusion revealed that sutures were associated with reduced wound infection rates compared to staples in six retrospective studies with potentially beneficial effects of Silverloin wound dressings. Still, data were derived from six lower quality retrospective studies (evidence level III) and several questions could not be adequately answered [ 14 ]. The present study contributes a prospective, multicentric approach, offering a more robust understanding of the comparative impact of these closure techniques. A low rate of superficial surgical site infections was seen in both groups, with only two cases of A1 wound infections within 30 days after surgery, one in each group. No wound infection greater A1 was detected. This 1%-infection rate aligns with current evidence, which reports a pooled incidence of superficial SSI at 1.4% in a comprehensive systematic review and meta-analysis [ 1 ]. The homogeneous patient population across three participating centers adds credibility to our results. Intraoperative data were evenly distributed between the two groups with a significantly shorter duration of skin closure in the staple-assisted suture group. Speed in skin closure translates into a more efficient workflow exploiting both less surgical time, duration of anesthesia and cost containment [ 15 ]. However, this discrepancy in closure time did not translate into a significant difference in overall surgical duration, suggesting that while staple-assisted closure might save time during skin closure, it does not significantly impact the entire surgical procedure's duration. This finding is consistent with previous research comparing the efficiency of these closure techniques in various surgical contexts [ 16 ]. Our study is not without limitations. While our patient population was homogenous and the study design was multicentric, the sample size was limited and loss of follow up was a challenge primarily due to travel distance, non-compliance, and the impact of the COVID-19 lockdown during the initial study period. Attempts were made to mitigate this issue by conducting telephone interviews, and some patients provided photographs via email to confirm reported wound healing status. Additionally, a longer-term follow-up to assess the incidence of delayed infections and patient-reported outcomes might have provided a more comprehensive perspective on the comparative effectiveness as well as the inclusion of higher-risk patient cohorts, such as those undergoing multi-level instrumented spine surgeries or recurrent surgeries. Ultimately, this study focused on wound infection aspects only and not on long-term cosmetic outcomes, an area of potential concern for patients [ 17 ]. Moreover, having an independent observer involved in the follow-up assessed might have help mitigate other potential biases. In conclusion, our prospective multicenter study found a low incidence of superficial surgical site infections with no significant difference between intracutaneous sutures and staple-assisted closure in non-instrumented lumbar spine surgery. Although staple-assisted closure was faster, it did not reduce the overall surgical time. Future studies with larger sample sizes and independent follow-up assessments are necessary to further explore these results. Our preliminary findings suggest that the choice between both techniques can be guided by specific clinical scenarios and ultimately surgeon preference. Declarations Acknowledgements The authors thank all the subjects who participated in the study and the support/research coordinator staff and investigators from the three contributing sites. No funds, grants, or other support was received for this research. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements) or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. Conflict of Interest No funding was received for this research. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers' bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript was received for this research. ETHICAL APPROVAL All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was reviewed and approved by institutional review boards. 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Surg Neurol Int 13:534. doi: 10.25259/SNI_872_2022 Yilmaz E, Blecher R, Moisi M, Ankush C, O'Lynnger TM, Abdul-Jabbar A, Dettori JR, Oskouian RJ (2018) Is There an Optimal Wound Closure Technique for Major Posterior Spine Surgery? A Systematic Review. Global Spine J 8:535-544. doi: 10.1177/2192568218774323 Anderson PA, Savage JW, Vaccaro AR, Radcliff K, Arnold PM, Lawrence BD, Shamji MF (2017) Prevention of Surgical Site Infection in Spine Surgery. Neurosurgery 80:S114-S123. doi: 10.1093/neuros/nyw066 Krishnan RJ, Crawford EJ, Syed I, Kim P, Rampersaud YR, Martin J (2019) Is the Risk of Infection Lower with Sutures than with Staples for Skin Closure After Orthopaedic Surgery? A Meta-analysis of Randomized Trials. Clin Orthop Relat Res 477:922-937. doi: 10.1097/CORR.0000000000000690 Quiring K, Lorio MP, León JFR, de Carvalho PST, Fiorelli RKA, Lewandrowski KU (2023) Patient Perceptions of Paramedian Minimally Invasive Spine Skin Incisions. J Pers Med 13:878. doi: 10.3390/jpm13060878 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 13 Aug, 2024 Read the published version in Acta Neurochirurgica → Version 1 posted Editorial decision: Revision requested 11 Jul, 2024 Reviews received at journal 10 Jul, 2024 Reviews received at journal 02 Jul, 2024 Reviewers agreed at journal 13 Jun, 2024 Reviewers agreed at journal 13 Jun, 2024 Reviewers invited by journal 03 Jun, 2024 Submission checks completed at journal 03 Jun, 2024 Editor assigned by journal 03 Jun, 2024 First submitted to journal 01 Jun, 2024 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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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4512742","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":314204759,"identity":"248e79cf-9434-4f7f-b6ff-b92d4d931905","order_by":0,"name":"Alexander Romagna","email":"data:image/png;base64,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","orcid":"","institution":"University Hospital Salzburg, Paracelsus Medical University","correspondingAuthor":true,"prefix":"","firstName":"Alexander","middleName":"","lastName":"Romagna","suffix":""},{"id":314204760,"identity":"c83d531a-eec3-4e45-b9e3-b1b070c03d27","order_by":1,"name":"Jens Lehmberg","email":"","orcid":"","institution":"München Klinik Bogenhausen","correspondingAuthor":false,"prefix":"","firstName":"Jens","middleName":"","lastName":"Lehmberg","suffix":""},{"id":314204761,"identity":"fa10b144-a353-4452-ae97-6025760cebff","order_by":2,"name":"Michael Meier","email":"","orcid":"","institution":"München Klinik Bogenhausen","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"","lastName":"Meier","suffix":""},{"id":314204762,"identity":"781b911b-23b1-4df1-8140-cb9ecf043061","order_by":3,"name":"Michael Stelzer","email":"","orcid":"","institution":"München Klinik Bogenhausen","correspondingAuthor":false,"prefix":"","firstName":"Michael","middleName":"","lastName":"Stelzer","suffix":""},{"id":314204763,"identity":"ac4623c9-5fc8-4a77-89a6-5bca210ed7a8","order_by":4,"name":"Arwin Rezai","email":"","orcid":"","institution":"University Hospital Salzburg, Paracelsus Medical University","correspondingAuthor":false,"prefix":"","firstName":"Arwin","middleName":"","lastName":"Rezai","suffix":""},{"id":314204764,"identity":"9716b226-1024-4814-b3a7-7d6d2055056b","order_by":5,"name":"Jürgen Volker Anton","email":"","orcid":"","institution":"University Hospital Salzburg, Paracelsus Medical University","correspondingAuthor":false,"prefix":"","firstName":"Jürgen","middleName":"Volker","lastName":"Anton","suffix":""},{"id":314204765,"identity":"c14966c1-8972-4255-a717-1a3e087565b2","order_by":6,"name":"Albert Eckert","email":"","orcid":"","institution":"University Hospital Salzburg, Paracelsus Medical University","correspondingAuthor":false,"prefix":"","firstName":"Albert","middleName":"","lastName":"Eckert","suffix":""},{"id":314204766,"identity":"e0657bdf-b657-4b97-ac60-c9aa7e1fa9ac","order_by":7,"name":"Christoph J. 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cohort)\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4512742/v1/a0915b950ebc0de48e86145c.png"},{"id":58517340,"identity":"72e21237-141e-4554-a51e-d633c0aab620","added_by":"auto","created_at":"2024-06-17 16:55:30","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":595713,"visible":true,"origin":"","legend":"\u003cp\u003eIllustrative case depicting the 6-day follow-up (A) and the 30-day follow-up (B) with evidence of an A1 SSSI in the latter\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4512742/v1/b4857aabb1e44ffaf1d9f1c0.png"},{"id":58517341,"identity":"5811de8c-a5a5-42e5-94e3-e247268ba449","added_by":"auto","created_at":"2024-06-17 16:55:30","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":40896,"visible":true,"origin":"","legend":"\u003cp\u003eIntraoperative data emphasize the rapidity of staple-assisted closure and highlight its independence from incision length\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-4512742/v1/57ea4e7bd048c62fe5fe91df.png"},{"id":63071038,"identity":"168330fc-da95-48e7-8bbc-89f41fd0f63e","added_by":"auto","created_at":"2024-08-22 20:03:07","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1573147,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4512742/v1/efe512ce-7663-4399-a377-3429f8173b5c.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003ePostoperative wound infections following spine surgery occur at a frequency of 1\u0026ndash;6% [\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Although this rate might appear small, it is a persistent cause of elevated morbidity and treatment costs in modern day spine surgery. While there are some surgeon-independent factors influencing this problem, the process of skin closing is commonly determined by the surgeon and/or departmental preferences [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Among various options, the decision between using intracutaneous sutures versus staple-assisted wound closure is of particular interest because both techniques are widely used. Each technique has its own potential advantages: while intracutaneous sutures are believed to create an internal barrier against potential contaminants, staple-assisted closure may offer a time advantage and superior ease of use [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. In elective gastrointestinal surgery, a large prospective randomized study comparing both techniques failed to demonstrate a lower rate of superficial wound infections in intracutaneous suturing compared to staple-assisted closure but less wound dehiscence in the former [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Although there has been a substantial increase in evidence on wound closure techniques in spine surgery, most data are hampered by their retrospective, monocentric and heterogenous nature [\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Obtaining an improved understanding of which wound closure is superior has the potential to guide surgical decision-making. In this study, we prospectively compared the randomized use of intracutaneous sutures and staple-assisted closure after lumbar spine surgery in a multicentric cohort.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and patients\u003c/h2\u003e \u003cp\u003eThis study is a multicenter prospective randomized trial of patients undergoing non-instrumented lumbar primary spine surgery. Patient recruitment was performed at three Central European centers. In one study cohort the skin was closed with a single-use skin stapler with stainless steel staples (Covidien, Mansfield, MA) and in the other study cohort the skin was closed intracutaneously with absorbable sutures (either Monosyn\u0026reg;, B. Braun Surgical SA, Rub\u0026iacute;, Spain or V-Loc\u0026trade; wound closure device, Covidien, Mansfield, MA). All ethics committees reviewed the study protocol (approval numbers 785/20 S-SR and 1094/2021). We included patients who were about to undergo non-instrumented primary surgery at the lumbar spine and the thoracolumbar junction via a posterior midline approach. These procedures comprised uni- or multilevel microscopic decompression of the spinal canal for spinal canal stenosis or disc herniation. Patients with prior surgery at the same or at an adjacent level, prior antibiotic treatment (within two weeks prior to surgery) or patients who were planned to receive any type of instrumentation were excluded. Cephalosporins were most commonly used for perioperative antimicrobial prophylaxis to prevent surgical site infection. The primary endpoint of the study was the occurrence of an A1 SSSI (skin/subcutaneous tissue) as described in the CDC classification system for surgical site infections within 30 days after the procedure [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Secondary endpoints were perioperative data i.e. blood loss, cerebrospinal fluid (CSF) leaks and the duration of skin closure.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy protocol\u003c/h2\u003e \u003cp\u003eParticipating patients were randomized to the intracutaneous suture or staple-assisted closure by alternation coordinated by each study center. All patients\u0026rsquo; gave written informed consent to the scheduled surgical procedure and study participation; no patients were lost or retracted their participation agreement after study inclusion and randomization. The lead surgeon was informed shortly before skin closure. Patients were then followed-up on the 6th and 30th day by the study doctors and the study nurse and results were documented photographically and on a multicentrally used follow-up sheet. Skin staples were usually removed on the 7th to 10th postoperative day while absorbable intracutaneous sutures did not require any removal. In case of re-operation the patient was excluded from further follow-up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe study cohort was characterized using means and standard deviations to describe continuous variables and proportions to describe categorical variables. Outcome data analysis was performed as per protocol. Primary endpoint analysis was planned using descriptive statistics. Secondary endpoints and perioperative patient data were analyzed by exploratory descriptive analysis as well as using the Wilcoxon-Mann-Whitney test to detect differences between the groups. A p-value below 0.05 was used as criterion for statistically significant difference throughout all analyses. All statistical calculations were performed with R and SPSS Statistics.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the study period from May 2021 to July 2023, a total of 207 patients were randomized and included in the analysis. Ninety-seven (46.9%) patients were randomized to the intracutaneous suture group, and 110 (53.1%) patients to the staple-assisted closure cohort; the study population was homogeneous for assessed patient characteristics (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e1\u003c/span\u003e). No differences in age (p\u0026thinsp;=\u0026thinsp;0.857) and sex (p\u0026thinsp;=\u0026thinsp;0,737) distributions was seen between participating centers. Skin closure times stratified by surgical techniques of all centers are displayed in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. An A1 SSSI within 30 days after surgery was found in two cases only (one in each cohort; illustrative case in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Both patients were smokers and one of them additionally suffered from diabetes type II. Both infections healed without any additional surgical treatment and without causing any disabling long-term sequelae. No A2 and A3 wound infections as defined by the CDC classification system for surgical site infections were observed. Maximum missing values were 26 for the total variable \u0026ldquo;median lumbar subcutaneous fat tissue thickness\u0026rdquo; as shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Intraoperative data, including metrics such as duration of surgery, length of incision as well as the location and the extent of operated levels, were evenly distributed between the two groups and across all three participating centers (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e2\u003c/span\u003e; maximum missing values were 45 for the total variable \u0026ldquo;length of incision\u0026rdquo;). The same was found for blood loss and incidences of CSF leaks. The duration of skin closure was on average longer in the intracutaneous suture group (198 seconds) compared to the staple-assisted closure group (13 seconds, U\u0026thinsp;=\u0026thinsp;147, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001; Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e2\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). This was independent from the length of the incision (shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) but did not influence the overall median surgical time (intracutaneous suture group 73 minutes vs. staple-assisted closure group 78 minutes, U\u0026thinsp;=\u0026thinsp;4493 p\u0026thinsp;=\u0026thinsp;0.238). Thirty-one (15%) patients were lost to follow up due to various reasons including travel distance, non-compliance and in the first period the COVID-19 lockdown. All data that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBasic population characteristics.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAll patients\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;207\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntracutaneous suture group\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;97\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStaple-assisted closure group\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;110\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian Age (years)\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57.4 (42-72.5)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e57.7 (42\u0026ndash;73)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e57.2 (42.3\u0026ndash;69.6)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003cp\u003emale\u003c/p\u003e \u003cp\u003efemale\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e122 (58.9%)\u003c/p\u003e \u003cp\u003e85 (41.1%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59 (60.8%)\u003c/p\u003e \u003cp\u003e38 (39.2%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e63 (57.3%)\u003c/p\u003e \u003cp\u003e47 (42.7%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian body mass index\u003c/b\u003e\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.1 (24-29.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24.3 (24-29.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25.8 (24-29.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian American Society of Anesthesiologists Score\u003c/b\u003e\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (2\u0026ndash;3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (2\u0026ndash;3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (2\u0026ndash;3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian lumbar subcutaneous fat tissue thickness (mm)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (15\u0026ndash;33)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23 (14-33.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23 (17\u0026ndash;30)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes yes\u003c/b\u003e\u003c/p\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e29 (14%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18 (18.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11 (10%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSteroid treatment\u003c/b\u003e\u003c/p\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (2.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (2.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (2.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNicotine abusus\u003c/b\u003e\u003c/p\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e82 (39.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38 (39.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e44 (40%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003eNo significant differences between treatment groups for all evaluated parameters were detected (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSurgery characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntracutaneous suture group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStaple-assisted closure group\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian surgery duration in min*\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75 (58.8\u0026ndash;100)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e73 (59\u0026ndash;90)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e78 (58.5\u0026ndash;103)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian incision length in mm\u003c/p\u003e \u003cp\u003e(IQR)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40 (35\u0026ndash;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e40 (35\u0026ndash;50)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e40 (35\u0026ndash;50)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eLumbar location\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eMonosegemental\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eBisegmental\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eTrisegmental\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e203 (98.1%)\u003c/p\u003e \u003cp\u003e170 (82.1%)\u003c/p\u003e \u003cp\u003e27 (13%)\u003c/p\u003e \u003cp\u003e6 (2.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e94 (96.9%)\u003c/p\u003e \u003cp\u003e84 (86.6%)\u003c/p\u003e \u003cp\u003e9 (9.3%)\u003c/p\u003e \u003cp\u003e1 (1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e109 (99.1%)\u003c/p\u003e \u003cp\u003e86 (78.2%)\u003c/p\u003e \u003cp\u003e18 (16.4%)\u003c/p\u003e \u003cp\u003e5 (4.5%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eUse of redon drain\u003c/b\u003e\u003c/p\u003e \u003cp\u003etotal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75 (36.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32 (33%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43 (39.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMedian Blood loss (ml)\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003e(IQR)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e156 (10\u0026ndash;600)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e118 (10\u0026ndash;600)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e187 (30\u0026ndash;500)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCerebrospinal fluid leaks\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003etotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (7.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (8.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (7.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003e*\u003c/b\u003eSignificant difference between treatment groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eSuperficial surgical site infections are a significant concern in spine surgery due to their potential sequelae [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. This study aimed to address this concern by comparing the impact of two commonly used skin closure techniques, intracutaneous sutures and staple-assisted closure, on wound healing and infection rates in non-instrumented primary spine surgery [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Our study\u0026rsquo;s main finding were i) the rate of infections was generally low in both cohorts and independent of the applied skin closure technique, and ii) closure with staples was the faster option which, however, did not significantly impact the total operating time.\u003c/p\u003e \u003cp\u003eSuperficial site infections have been a persistent issue in all surgical fields [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Previous research comparing these two specific techniques in elective gastrointestinal surgery did not find a lower rate of superficial wound infections in intracutaneous suturing compared to staple-assisted closure but did identify less wound dehiscence in the former [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn contrast, the available literature concerning wound closure methods in spine surgery is mostly retrospective, monocentric and heterogeneous by including instrumented fusion procedures as well as revision surgeries [\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. For instance, a systematic review by Yilmaz et al. on posterior spinal fusion revealed that sutures were associated with reduced wound infection rates compared to staples in six retrospective studies with potentially beneficial effects of Silverloin wound dressings. Still, data were derived from six lower quality retrospective studies (evidence level III) and several questions could not be adequately answered [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe present study contributes a prospective, multicentric approach, offering a more robust understanding of the comparative impact of these closure techniques. A low rate of superficial surgical site infections was seen in both groups, with only two cases of A1 wound infections within 30 days after surgery, one in each group. No wound infection greater A1 was detected. This 1%-infection rate aligns with current evidence, which reports a pooled incidence of superficial SSI at 1.4% in a comprehensive systematic review and meta-analysis [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The homogeneous patient population across three participating centers adds credibility to our results. Intraoperative data were evenly distributed between the two groups with a significantly shorter duration of skin closure in the staple-assisted suture group. Speed in skin closure translates into a more efficient workflow exploiting both less surgical time, duration of anesthesia and cost containment [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, this discrepancy in closure time did not translate into a significant difference in overall surgical duration, suggesting that while staple-assisted closure might save time during skin closure, it does not significantly impact the entire surgical procedure's duration. This finding is consistent with previous research comparing the efficiency of these closure techniques in various surgical contexts [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eOur study is not without limitations. While our patient population was homogenous and the study design was multicentric, the sample size was limited and loss of follow up was a challenge primarily due to travel distance, non-compliance, and the impact of the COVID-19 lockdown during the initial study period. Attempts were made to mitigate this issue by conducting telephone interviews, and some patients provided photographs via email to confirm reported wound healing status. Additionally, a longer-term follow-up to assess the incidence of delayed infections and patient-reported outcomes might have provided a more comprehensive perspective on the comparative effectiveness as well as the inclusion of higher-risk patient cohorts, such as those undergoing multi-level instrumented spine surgeries or recurrent surgeries. Ultimately, this study focused on wound infection aspects only and not on long-term cosmetic outcomes, an area of potential concern for patients [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Moreover, having an independent observer involved in the follow-up assessed might have help mitigate other potential biases.\u003c/p\u003e \u003cp\u003eIn conclusion, our prospective multicenter study found a low incidence of superficial surgical site infections with no significant difference between intracutaneous sutures and staple-assisted closure in non-instrumented lumbar spine surgery. Although staple-assisted closure was faster, it did not reduce the overall surgical time. Future studies with larger sample sizes and independent follow-up assessments are necessary to further explore these results. Our preliminary findings suggest that the choice between both techniques can be guided by specific clinical scenarios and ultimately surgeon preference.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank all the subjects who participated in the study and the support/research coordinator staff and investigators from the three contributing sites.\u003c/p\u003e\n\u003cp\u003eNo funds, grants, or other support was received for this research. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers\u0026apos; bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements) or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConflict of Interest\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received for this research. All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers\u0026apos; bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript was received for this research.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eETHICAL APPROVAL\u003c/p\u003e\n\u003cp\u003eAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol was reviewed and approved by institutional review boards.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eZhou J, Wang R, Huo X, Xiong W, Kang L, Xue Y (2020) Incidence of Surgical Site Infection After Spine Surgery: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976) 45:208-216\u003c/li\u003e\n \u003cli\u003eO\u0026apos;Toole JE, Eichholz KM, Fessler RG (2009) Surgical site infection rates after minimally invasive spinal surgery. J Neurosurg Spine 11:471-476. doi: 10.3171/2009.5.SPINE08633\u003c/li\u003e\n \u003cli\u003eZileli M (2023) Complication Avoidance in Spine Surgery. Acta Neurochir Suppl 130:141-156. doi: 10.1007/978-3-030-12887-6_18\u003c/li\u003e\n \u003cli\u003eMaurer E, Reuss A, Maschuw K, Aminossadati B, Neubert T, Schade-Brittinger C, Bartsch DK (2019) Superficial Surgical Site Infection Following the Use of Intracutaneous Sutures Versus Staples. Dtsch Arztebl Int 116:365-371. doi: 10.3238/arztebl.2019.0365\u003c/li\u003e\n \u003cli\u003eJohnston SS, Fortin SP, Pracyk JB, Tommaselli GA, Elangovanraaj N, Chen BP (2021) 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. Spine J 21:45-54. doi: 10.1016/j.spinee.2020.08.017\u003c/li\u003e\n \u003cli\u003eAndo M, Tamaki T, Yoshida M, Sasaki S, Toge Y, Matsumoto T, Maio K, Sakata R, Fukui D, Kanno S, Nakagawa Y, Yamada H (2014) Surgical site infection in spinal surgery: a comparative study between 2-octyl-cyanoacrylate and staples for wound closure. Eur Spine J 23:854-862. doi: 10.1007/s00586-014-3202-5\u003c/li\u003e\n \u003cli\u003eMostofi K, Peyravi M, Shirbacheh A, Shirbache K (2023) A comparison between different suture techniques in lumbar spine surgery. Int Wound J 20:296-301. doi: 10.1111/iwj.13875\u003c/li\u003e\n \u003cli\u003eMangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR (1999) Guideline for Prevention of Surgical Site Infection. Am J Infect Control 27:97-132\u003c/li\u003e\n \u003cli\u003eYao R, Zhou H, Choma TJ, Kwon BK, Street J (2018) Surgical Site Infection in Spine Surgery: Who Is at Risk? Global Spine J 8:5S-30S. doi: 10.1177/2192568218799056\u003c/li\u003e\n \u003cli\u003eWang X, Lin Y, Yao W, Zhang A, Gao L, Feng F (2023) Surgical site infection in spinal surgery: a bibliometric analysis. J Orthop Surg Res 18:337. doi: 10.1186/s13018-023-03813-6\u003c/li\u003e\n \u003cli\u003eSuter A, Spirig JM, Fornaciari P, Bachmann E, G\u0026ouml;tschi T, Klein K, Farshad M (2019) Watertightness of wound closure in lumbar spine-a comparison of different techniques. J Spine Surg 5:358-364. doi: 10.21037/jss.2019.08.01\u003c/li\u003e\n \u003cli\u003eSeidelman JL, Mantyh CR, Anderson DJ (2023) Surgical Site Infection Prevention: A Review. JAMA 329:244-252. doi: 10.1001/jama.2022.24075\u003c/li\u003e\n \u003cli\u003eAguilar OJM, Sida KKA, Betancourt L\u0026Aacute;, Olvera MD, Bernaldez GIL, L\u0026oacute;pez RL, Oropeza EO, Ornelas HAT (2022) Variability in wound closure technique in midline posterior lumbar fusion surgery. International survey and standardized closure technique proposal. Surg Neurol Int 13:534. doi: 10.25259/SNI_872_2022\u003c/li\u003e\n \u003cli\u003eYilmaz E, Blecher R, Moisi M, Ankush C, O\u0026apos;Lynnger TM, Abdul-Jabbar A, Dettori JR, Oskouian RJ (2018) Is There an Optimal Wound Closure Technique for Major Posterior Spine Surgery? A Systematic Review. Global Spine J 8:535-544. doi: 10.1177/2192568218774323\u003c/li\u003e\n \u003cli\u003eAnderson PA, Savage JW, Vaccaro AR, Radcliff K, Arnold PM, Lawrence BD, Shamji MF (2017) Prevention of Surgical Site Infection in Spine Surgery. Neurosurgery 80:S114-S123. doi: 10.1093/neuros/nyw066\u003c/li\u003e\n \u003cli\u003eKrishnan RJ, Crawford EJ, Syed I, Kim P, Rampersaud YR, Martin J (2019) Is the Risk of Infection Lower with Sutures than with Staples for Skin Closure After Orthopaedic Surgery? A Meta-analysis of Randomized Trials. Clin Orthop Relat Res 477:922-937. doi: 10.1097/CORR.0000000000000690\u003c/li\u003e\n \u003cli\u003eQuiring K, Lorio MP, Le\u0026oacute;n JFR, de Carvalho PST, Fiorelli RKA, Lewandrowski KU (2023) Patient Perceptions of Paramedian Minimally Invasive Spine Skin Incisions. J Pers Med 13:878. doi: 10.3390/jpm13060878\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"acta-neurochirurgica","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"anch","sideBox":"Learn more about [Acta Neurochirurgica](http://link.springer.com/journal/701)","snPcode":"701","submissionUrl":"https://submission.springernature.com/new-submission/701/3","title":"Acta Neurochirurgica","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Intracutaneous suture, lumbar spine surgery, staples, superficial surgical site infection, wound healing","lastPublishedDoi":"10.21203/rs.3.rs-4512742/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4512742/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eSuperficial surgical site infection (SSSI) is a prominent problem in spine surgery. Intracutaneous sutures and staple-assisted closure are two widely used surgical techniques for skin closure. Yet, their comparative impact on wound healing and infection rates is underexplored. Our goal was to address this gap and compare wound healing between these two techniques.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis study was a multicenter international prospective randomized trial. Patient data were prospectively collected at three large academic centers, patients who underwent non-instrumented lumbar primary spine surgery were included. Patients were intraoperatively randomized to either intracutaneous suture or staple-assisted closure cohorts. The primary endpoint was SSSI within 30 days after surgery according to the wound infection Centers for Disease Control and Prevention (CDC) classification system.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf 207 patients, 110 were randomized to intracutaneous sutures and 97 to staple-assisted closure. Both groups were homogenous with respect to epidemiological as well as surgical parameters. Two patients (one of each group) suffered from an A1 wound infection at the 30-day follow up. Median skin closure time was faster in the staple-assisted closure group (198 seconds vs. 13 seconds, p\u0026thinsp;\u0026lt;\u0026thinsp;0,001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThis study showed an overall low superficial surgical site infection rate in both patient cohorts in primary non instrumented spine surgery.\u003c/p\u003e","manuscriptTitle":"Wound healing after intracutaneous vs. staple-assisted skin closure in lumbar, non-instrumented spine surgery: a multicenter prospective randomized trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-17 16:55:25","doi":"10.21203/rs.3.rs-4512742/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-07-11T11:36:13+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-10T17:46:38+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-07-02T16:07:52+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"121932813546531095985845325283715501933","date":"2024-06-13T16:20:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"191625284433147988238697929125115627945","date":"2024-06-13T14:38:54+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-06-03T10:19:05+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-06-03T07:30:33+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-03T07:30:33+00:00","index":"","fulltext":""},{"type":"submitted","content":"Acta Neurochirurgica","date":"2024-06-01T08:39:01+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"acta-neurochirurgica","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"anch","sideBox":"Learn more about [Acta Neurochirurgica](http://link.springer.com/journal/701)","snPcode":"701","submissionUrl":"https://submission.springernature.com/new-submission/701/3","title":"Acta Neurochirurgica","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"7346a466-2e73-4d0c-9682-0db9a196ac1e","owner":[],"postedDate":"June 17th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-08-22T19:31:41+00:00","versionOfRecord":{"articleIdentity":"rs-4512742","link":"https://doi.org/10.1007/s00701-024-06227-3","journal":{"identity":"acta-neurochirurgica","isVorOnly":false,"title":"Acta Neurochirurgica"},"publishedOn":"2024-08-13 15:57:27","publishedOnDateReadable":"August 13th, 2024"},"versionCreatedAt":"2024-06-17 16:55:25","video":"","vorDoi":"10.1007/s00701-024-06227-3","vorDoiUrl":"https://doi.org/10.1007/s00701-024-06227-3","workflowStages":[]},"version":"v1","identity":"rs-4512742","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4512742","identity":"rs-4512742","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}