Practice of a Pharmacy-Led Multidisciplinary Collaborative Closed-Loop Management Model in the Prophylactic Use of Antimicrobial Agents During the Perioperative Period of Orthopedic Class I Incision Surgeries

Practice of a Pharmacy-Led Multidisciplinary Collaborative Closed-Loop Management Model in the Prophylactic Use of Antimicrobial Agents During the Perioperative Period of Orthopedic Class I Incision Surgeries | 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 Practice of a Pharmacy-Led Multidisciplinary Collaborative Closed-Loop Management Model in the Prophylactic Use of Antimicrobial Agents During the Perioperative Period of Orthopedic Class I Incision Surgeries Mimi Wang, Ye Zhang, Ning Cao, Zhangxuan Shou, Rongbo Zhang This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7894262/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Objective: To evaluate the efficacy of a pharmacy-led multidisciplinary collaborative closed-loop management model in improving the rational use of perioperative prophylactic antimicrobial agents in orthopedic Class I incision surgeries. Methods: A pharmacy-led multidisciplinary collaborative closed-loop management model involving pharmacy, clinical departments, medical administration, and hospital infection control was established to address irrational prophylactic antimicrobial use in orthopedic Class I incision surgeries at our hospital. Medical records of all patients undergoing Class I incision surgeries in the orthopedic department from January 2022 to December 2024 were retrospectively reviewed. The intervention effects were assessed by comparing six key aspects before and after implementation: indications for antimicrobial use, drug selection, timing of administration, dosage and frequency, combination therapy, and duration of prophylaxis. Rseults: Following the intervention, the prophylactic antimicrobial use rate decreased from 60.51% to 53.48% (P 0.05). The rational drug selection rate improved from 61.03% to 97.46% (P < 0.05). The rational dosage and frequency rate rose from 83.57% to 100% (P < 0.05). The rational combination therapy rate increased from 96.24% to 99.84% (P < 0.05). The compliance rate for optimal timing of administration improved from 81.69% to 90.32%, and the rational duration of prophylaxis increased from 12.68% to 71.43% (P < 0.05). Conclusion: The pharmacy-led multidisciplinary collaborative closed-loop management model effectively enhances the rational use of perioperative prophylactic antimicrobial agents in orthopedic Class I incision surgeries, demonstrating high feasibility and broad applicability. Pharmacy-Led Multidisciplinary collaboration Closed-loop management Orthopedic Class I Incision Surgeries Prophylactic use Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The appropriate use of perioperative antimicrobials plays a vital role in preventing surgical site infections, protecting patient safety, and promoting recovery. Standardized antimicrobial administration serves as a fundamental strategy for surgical infection control, influencing both clinical outcomes and public health. Despite its importance, current clinical practices often demonstrate inappropriate antimicrobial use, which contributes to antimicrobial resistance, inefficient resource utilization, and increased healthcare costs, representing a major global challenge in medical quality [1-4] . Since 2011, the National Health Commission has issued several regulatory documents concerning antimicrobial use management, including the Guidelines for Clinical Application of Antimicrobial Agents [5] and the Notice on Continuous Improvement of Clinical Antimicrobial Use Management. These policies have specifically targeted perioperative prophylactic antimicrobial use in Class I incisions as a key focus area for antimicrobial stewardship, aiming to reduce excessive reliance on antimicrobial prophylaxis for surgical site infections. The prophylactic antimicrobial usage rate in Class I incision surgeries has been incorporated as a critical indicator in hospital accreditation evaluations and national healthcare quality assessments, with the objective of promoting standardized and rational clinical antimicrobial use. However, clinical practice reveals that excessive and inappropriate perioperative antimicrobial prophylaxis remains prevalent and severe in Class I incision surgeries across China [6] . This underscores the urgent need to develop more effective intervention strategies to optimize perioperative antimicrobial use, ensure medication safety, enhance therapeutic efficacy, and improve patient outcomes. Currently, various models such as the Quality Control Circle (QCC) model [7] , Lean Six Sigma method [8] , clinical pharmacist intervention [9–10] , Antimicrobial Stewardship (AMS) [11] , antimicrobial drug management [12,13] , and multidisciplinary team approac [14] have been applied to the management of perioperative antimicrobial agents. However, these approaches exhibit limitations, including significant but unsustainable efficacy, high specialization with limited coverage, and strong systematization but demanding requirements for informatization. A unified model has yet to be established. Although single-intervention models may achieve short-term desired outcomes [15,16] , they carry a risk of rebound, indicating the necessity for developing more sustainable management mechanisms. The Second Affiliated Hospital of Zhejiang Chinese Medical University is a tertiary Grade A comprehensive hospital integrating traditional Chinese and Western medicine, with orthopedics as its specialty. Among all Class I incision surgeries, orthopedic procedures account for the highest proportion. Characterized by prolonged operative duration, extended tissue exposure, and lengthy postoperative recovery periods, orthopedic surgeries represent one of the clinical departments with a high incidence of infectious diseases. Based on the aforementioned background and national policy directives, a multidisciplinary four-dimensional collaborative management framework involving pharmacy, clinical practice, medical administration, and hospital infection control was established. Utilizing the PDCA (Plan-Do-Check-Act) cycle as a closed-loop management pathway, a dual-track mechanism combining information-based implementation monitoring and manual review was implemented. Orthopedic-specific medication evaluation criteria were formulated to statistically investigate the prophylactic use of antimicrobial agents during the perioperative period for Class I incisions in orthopedic surgery. Comparative analyses were conducted across pre-intervention, intervention, and post-intervention phases to evaluate outcomes. This study explored a perioperative antimicrobial management model tailored to Class I incisions in our hospital setting, providing evidence-based support for standardizing prophylactic antimicrobial use and optimizing perioperative management protocols in clinical practice.The research findings hold significant practical value for enhancing the hospital's refined antimicrobial management system and achieving national health-care quality improvement objectives. Furthermore, this study offers replicable management experience for peer medical institutions. Ethical approval This study was conducted in accordance with the guidelines of the Helsinki Declaration and was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University of Chinese Medicine on August 5, 2025.(Project Number: 2025-113). 1. Clinical data Medical records of all patients undergoing Class I incision surgeries in the Department of Orthopedic from January 2022 to December 2024 were collected. The collected data included: Baseline characteristics (department, name, age, admission date, discharge date),Clinical diagnosis,Allergy history,Surgical details(surgery name, incision classification, operation duration, anesthesia duration),Prophylactic medication (indications, drug selection, dosage and administration, timing of administration, combination therapy, duration of use, etc.).Patients who underwent surgery from January 2022 to June 2022 were assigned to the pre-intervention group, those from July 2022 to June 2023 to the intervention group, and those from July 2023 to December 2024 to the post-intervention group. Methods 2.1 Establishment of a Pharmacy-Led Multidisciplinary Closed-Loop Management Model A pharmacst-led MDT was formed, integrating clinical departments, infection control, and medical administration. 2.1.1 Development of a Pharmacist-Led Pharmaceutical Care Model for Orthopedics Clinical pharmacists joined the orthopedic team, participating in ward rounds and assisting in formulating antimicrobial prophylaxis protocols for Class I incision surgeries. They conducted pre-prescription reviews, communicated with clinicians regarding identified issues, and engaged in consultations to promote rational antimicrobial use. Additionally, pharmacists collected comparative data on antimicrobial usage and SSI rates from peer institutions to guide clinical decisions. A proactive pharmaceutical care model was established, encompassing clinical rounds, patient assessment, antimicrobial regimen optimization, prescription review, pharmaceutical monitoring, and consultation. This transition from reactive to proactive pharmaceutical services enhanced clinicians' awareness of rational antimicrobial use. 2.1.2 Implementation of a Multidisciplinary Closed-Loop Management System An MDT involving pharmacy, clinical departments, medical administration, and infection control was formed. Pharmacists collaborated with clinicians to develop evaluation criteria for perioperative antimicrobial use in Class I incisions. Prescription reviews were intensified, with results reported to the medical administration and publicly disclosed on the hospital’s intranet. Regular updates on antimicrobial use, particularly for underperforming medical teams, were provided during hospital-wide meetings. The infection control department conducted preoperative antimicrobial usage audits and provided feedback to clinicians. Joint quality inspections by pharmacy and medical administration focused on perioperative antimicrobial use, with findings publicly reported. Clinicians with inappropriate prescribing practices were counseled by medical administration. Antimicrobial stewardship metrics were incorporated into departmental performance evaluations, influencing physician assessments, promotions, and commendations. 2.1.3 Optimization of the Antimicrobial Stewardship Formulary The absence of cefazolin and clindamycin in the hospital’s formulary limited prophylactic options for Class I incisions. Pharmacists conducted a reevaluation of existing antimicrobials, identifying redundant, low-efficacy, high-resistance, or high-adverse-effect agents with insufficient evidence-based support. Optimization proposals were submitted to the Antimicrobial Stewardship Working Group and the Pharmacy and Therapeutics Committee. Following deliberation, cefazolin and clindamycin were successfully added, refining the hospital’s antimicrobial classification and management system. 2.1.4 Development of a Training and Evaluation System for Antimicrobial Agents We have established a pyramid-shaped antimicrobial agent training and assessment system, structured as follows: - Base Level: Hospital-wide training and assessment. - Middle Level: Department-specific training. - Apex: Case review sessions focusing on orthopedic. Regular offline and online sessions, lectures, and academic salons covered rational perioperative antimicrobial use and formulary management. Educational materials, including “Guidelines for Rational Antimicrobial Use” and “Xinhua Pharmacy Bulletin” summarized evidence-based recommendations for orthopedic perioperative prophylaxis. Clinical pharmacists conducted one-on-one departmental training, tailoring content to surgical types and patient conditions. The multidisciplinary team goes to orthopedic wards to conduct surgical case - analysis meetings, discusses irrational drug - use cases, and offers references for other departments to promote the proper use of antimicrobial drugs. After training, doctors must pass relevant assessments to obtain the prescribing qualifications for corresponding antimicrobial drugs. 2.1.5 Enhancement of the Surgical Prophylaxis Information System An intelligent prescribing system was integrated into the electronic order system, enabling real-time access to drug monographs. For Class I incisions, the system utilized rule-based algorithms to assess indications and recommend standardized prophylactic regimens. Alerts were triggered for non-compliant orders, restricting further actions to reduce inappropriate selections. Dosage and administration limits were enforced. Preoperative antimicrobial administration was monitored via personal digital assistant (PDA) scanning by surgical nurses, recording precise start and end times to ensure administration within 0.5–1 hour before incision. An automatic stop-order system prevented prolonged courses due to delayed discontinuation. 2.2 Statistical Methods Data analysis was performed using SPSS 26.0.Continuous variables were expressed as mean ±s, and comparisons among multiple groups were conducted using one-way analysis of variance (ANOVA).Categorical variables were presented as counts or percentages and analyzed using the χ² test,P-value < 0.05 was considered statistically significant. Results 3.1. General Patient Characteristics A total of 2,381 orthopedic patients undergoing Class I incision surgerieswere enrolled from January 2022 to December 2024. No statistically significant differences were observed among the three groups in terms of gender and age (Table 1). Table 1 General information of patients with Type I incision surgery Group Number of Cases /n Gender/n Age/years Male Female Pre-intervention 352 152 200 60.36±18.56 During-intervention 851 378 473 62.55±17.79 Post-intervention 1178 464 714 61.44±17.76 3.2. Distribution of class I Incision Surgical Procedures and Antimicrobial Prophylaxis Utilization Rate The orthopedic Type I incision surgeries primarily included internal fixation, balloon kyphoplasty for thoracic/lumbar vertebral fractures, cervical/thoracic/lumbar spinal fusion, joint replacement, arthroscopic joint repair, ligament repair, and removal of internal fixation devices. The preoperative antimicrobial prophylaxis rate for orthopedic Type I incisions was 60.51% before the intervention, 59.17% during the intervention, and 51.71% after the intervention, with statistically significant differences (P < 0.05)（Figure 1）. 3.3.Evaluation of Rationality Indicators for Perioperative Antimicrobial Prophylaxis in Orthopedic Type I Incision Surgeries Indications for Prophylactic Use:Antimicrobial prophylaxis is indicated for Type I incision surgeries involving implant placement (e.g., internal fixation, artificial joint replacement) or spinal-related procedures, whereas it is generally unnecessary for procedures such as removal of internal fixation devices. The compliance rate was 94.37% before the intervention, 94.48% during the intervention, and 95.87% after the intervention, with no statistically significant difference (P>0.05).Combination Therapy:Single-agent antimicrobial prophylaxis is recommended for Type I incisions, without the need for combination therapy. The compliance rate for combination therapy improved from 96.24% before the intervention to 96.45% during the intervention and further to 99.84% after the intervention, with statistically significant differences (P < 0.05)（Figure 2）. Dosage and Administration: The prophylactic antimicrobial dosage should comply with the drug Instructions and antimicrobial guidelines. The compliance rate increased from 83.57% before the intervention to 88.76% during the intervention and reached 100% after the intervention. The optimal timing for prophylactic administration is 0.5~1 hour before skin or mucosal incision or at the initiation of anesthesia. The compliance rate for administration timing improved from 81.69% before the intervention to 86.79% during the intervention and further to 90.32% after the intervention, with statistically significant differences (P < 0.05)（Figure 3）. Antimicrobial Selection: First- and second-generation cephalosporins should be the primary choice for antimicrobial prophylaxis in orthopedic Type I incision surgeries. The compliance rate increased from 61.03% before the intervention to 72.98% during the intervention and further to 97.46% after the intervention. Duration of Prophylaxis: The prophylactic antimicrobial course for Type I incision surgeries should not exceed 24 hours. The compliance rate improved from 12.68% before the intervention to 41.62% during the intervention and further to 71.43% after the intervention, with statistically significant differences (P < 0.05)（Figure 4）. Discussion Class I incision surgeries involve uncontaminated sites without involvement of respiratory, digestive, or other body cavities communicating with the external environment, and thus typically do not require prophylactic antimicrobial agents. Since the national antimicrobial stewardship campaign was launched, healthcare institutions at all levels have implemented multiple proactive measures to promote rational antimicrobial use. As a traditional Chinese and Western medicine hospital with a strong orthopedic specialty, our institution performs a high volume of orthopedic surgeries. Consequently, perioperative prophylactic antimicrobial use in clean surgeries has been a key focus of management. Investigations revealed several irrational prescribing practices, including unclear indications for antimicrobial prophylaxis, inappropriate drug selection, improper timing of administration, and excessively prolonged duration of use—with the most prominent issue being unnecessarily prolonged prophylactic courses. To address these problems, this study established a closed-loop management model led by pharmacy and supported by a multidisciplinary team. This model centers on monitoring dynamic changes in rationality indicators, integrating corrective measures with continuous quality improvement to optimize perioperative prophylactic antimicrobial use in Class I incision surgeries. Although antimicrobial prophylaxis is generally unnecessary for Class I surgical wounds, it may be considered in cases involving extensive surgical fields, prolonged operative durations, critical organ involvement, foreign body implantation, or high-risk factors for infection (e.g., advanced age, diabetes, immunocompromised status, or malnutrition). According to relevant evaluation criteria, the prophylactic antimicrobial use rate should not exceed 30%. However, our findings indicate that the prophylactic use rate in orthopedic Class I surgical wounds exceeded this target both before and after the implementation of this model. This discrepancy primarily stems from the nature of orthopedic procedures at our institution, which predominantly involve internal fixation, joint replacement, artificial femoral head replacement (all involving foreign body implantation), and spinal surgeries (with or without implants). These procedures are characterized by extensive surgical fields, prolonged durations, and inherent infection risks, justifying antimicrobial prophylaxis. Additionally, our patient population includes a high proportion of elderly individuals (40.7% aged >70 years), who often exhibit reduced immunity and multiple comorbidities, further elevating infection risks and contributing to higher prophylactic use rates compared to other departments performing Class I surgeries. Nevertheless, some cases lacked clear indications for prophylaxis, such as internal fixation removal in patients without additional risk factors, where antimicrobial prophylaxis is typically unnecessary. For instance, arthroscopic rotator cuff repair—a common shoulder procedure—has been shown not to increase the incidence of superficial or deep shoulder infections when performed without antimicrobial prophylaxis [17] . Thus, unless foreign body implantation is involved, antimicrobial prophylaxis is unnecessary for this procedure. The most common pathogens in orthopedic surgical site infections (SSIs) are Gram-positive bacteria, particularly Staphylococcus aureus. First- and second-generation cephalosporins are the preferred prophylactic agents, with vancomycin (or norvancomycin) and clindamycin recommended for patients with cephalosporin allergies. Our pre-intervention data revealed irrational antimicrobial selection, predominantly involving cefoxitin, ceftriaxone, cefotaxime, isepamicin, and fluoroquinolones, with cephalosporins and third-generation cephalosporins accounting for 83% of inappropriate selections. Robust evidence underscores the importance of standardized antimicrobial selection: in orthopedic arthroplasty, first-generation cephalosporins significantly reduce periprosthetic joint infection rates compared to non-first-generation alternatives such as vancomycin or clindamycin [18] . A retrospective study on perioperative prophylaxis in hip and knee arthroplasty further demonstrated that non-cefazolin regimens (e.g., vancomycin, clindamycin, or others) were associated with an increased risk of SSIs [19] . Additionally, clinical observations indicate that patients with cephalosporin allergies who receive alternative prophylactic agents exhibit significantly higher SSI rates, particularly deep infections [20] . These findings highlight the critical role of rational antimicrobial selection in postoperative infection control. Strict adherence to antimicrobial selection principles is essential for reducing infection risks and enhancing surgical safety. Post-intervention, the rational antimicrobial selection rate reached 94.93%. Intravenous administration 0.5~1 hour before incision ensures adequate tissue drug concentrations during the critical period of surgical contamination, effectively reducing postoperative infections. Administration too early may result in subtherapeutic drug levels during the contamination phase, while delayed administration misses the optimal window for bacterial colonization control, increasing infection risks. Studies demonstrate that patients receiving antimicrobials >1 hour before lumbar fusion surgery exhibit significantly higher SSI rates [21] . Our investigation identified cases where preoperative administration occurred 1 hour before incision, likely due to scheduling challenges in sequential surgeries. Some patients received no preoperative prophylaxis, with antimicrobials initiated postoperatively in the ward. Additionally, intraoperative redosing was omitted in procedures lasting >3 hours or with blood loss exceeding 1500 ml, possibly reflecting knowledge gaps among surgeons. These issues improved significantly following model implementation. Excessively prolonged prophylactic durations remain the most common problem in perioperative antimicrobial use for orthopedic Class I wounds. Guidelines recommend prophylaxis not exceeding 24 hours. Although surgeons may prolong antimicrobial use due to concerns about SSIs leading to surgical failure, extended durations do not reduce infection risks but instead contribute to bacterial resistance, adverse effects, and increased financial burdens. Through this management model, the rational duration rate improved from 12.68% to 71.43%, though further optimization is needed. Future enhancements include electronic system refinements, such as defaulting prophylactic antimicrobial orders to one-time or 24-hour prescriptions to prevent inadvertent prolongation due to overlooked discontinuation orders. Conclusion The implementation of a pharmacy-led, multidisciplinary collaborative closed-loop management model, characterized by efficient interdisciplinary cooperation and proactive engagement, is essential for successful promotion and execution. The application of this model has significantly improved the rational use of perioperative prophylactic antibiotics for Class I incisions in orthopedics, particularly in optimizing drug selection, timing of administration, and duration of treatment. By integrating pharmacists into the clinical workflow, implementing real-time informatics-based feedback, and conducting multidisciplinary joint supervision, a dynamic intervention system has been established. This approach provides a replicable management pathway for peer institutions. Limitations ① This model has demonstrated partial efficacy in reducing both the utilization rate and rational use rate of perioperative prophylactic antibiotics for Class I incision patients in the orthopedic department. However, it has not yet met the requirement (<30% prophylactic antibiotic use rate for Class I incision surgeries) specified in the evaluation criteria for tertiary integrated traditional Chinese and Western medicine hospitals. Significant room for improvement remains, particularly regarding treatment duration. Subsequent interventions could incorporate experiences from other institutions by: (a) strengthening clinical pharmacists' leadership role, (b) establishing department-specific antibiotic use pathways for orthopedics, and (c) implementing daily postoperative medication indication assessment protocols to achieve refined antibiotic management. ② As a single-center study, the generalizability of findings may be limited by inclusion criteria and geographical constraints, potentially affecting the representativeness of the patient population's disease characteristics. Future multicenter real-world studies should incorporate data from hospitals across different regions and tiers, while employing stratified approaches to control confounding factors (e.g., surgical types, underlying diseases) to enhance the external validity of conclusions. ③ While administrative interventions currently play a pivotal role in this model, their sustainability remains challenging. Key strategies include: (a) institutionalizing temporary measures as core hospital protocols, (b) expanding the framework to encompass all surgical incision types hospital-wide based on institutional realities, and (c) progressively covering all surgical categories to standardize perioperative antibiotic use and management. This model provides empirical evidence for antibiotic stewardship in integrated traditional Chinese and Western medicine hospitals. Subsequent research should incorporate health economic evaluations (e.g., cost-benefit analyses) to further validate its scalability. Concurrently, the integration with Diagnosis-Related Groups (DRG) payment reforms could incorporate rational medication metrics into performance evaluation systems, achieving tripartite optimization among administration, clinical practice, and healthcare financing. Declarations Ethics approval and consent to participate This study was conducted in accordance with the guidelines of the Helsinki Declaration and was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University of Chinese Medicine on August 5, 2025.(Project Number: 2025-113).The ethics committee granted a waiver of informed consent for this study. Consent for publication Consent for publication is not applicable as this manuscript does not contain any individual person's data in any form. Availability of data and materials All the data and supportive information are provided within the article. Declaration of conflicting interest The authors declare that they have no conflict of interest. Funding This work was not supported by any funding. Authors' contributions All authors have contributed to the design and conceptualization of the research. Research selection, data collection, data analysis, and contact with authors included in the study to obtain more information were conducted by M, Y, N, Z, and R. M drafted this paper. Z further revised the text. The final version of this article has been reviewed and approved by M, Y, N, Z, and R. Acknowledgements ： Not applicable References Eckmann C, Aghdassi SJS, Brinkmann A, et al. Perioperative Antibiotic Prophylaxis—Indications and Modalities for the Prevention of Postoperative Wound Infection. Dtsch Arztebl Int. 2024 Apr 5;121(7):233-242. Santoshi JA, Behera P, Nagar M, et al. Current Surgical Antibiotic Prophylaxis Practices: A Survey of Orthopaedic Surgeons in India. Indian J Orthop. 2020 Nov 18;55(3):749-757. Mwita JC, Ogunleye OO, Olalekan A, et al. Key Issues Surrounding Appropriate Antibiotic Use for Prevention of Surgical Site Infections in Low- and Middle-Income Countries: A Narrative Review and the Implications. Int J Gen Med. 2021 Feb;14:515-530. 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World Neurosurg. 2021 Sep;153:e349-e358. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 26 Dec, 2025 Reviewers invited by journal 02 Nov, 2025 Editor invited by journal 31 Oct, 2025 Editor assigned by journal 30 Oct, 2025 Submission checks completed at journal 30 Oct, 2025 First submitted to journal 18 Oct, 2025 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. We do this by developing innovative software and high quality services for the global research community. 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1","display":"","copyAsset":false,"role":"figure","size":14173,"visible":true,"origin":"","legend":"\u003cp\u003eThe prophylactic utilization rate of antibacterial drugs during the perioperative period for class I incisions\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7894262/v1/0be1c2436731d548cf54f5ab.png"},{"id":95807093,"identity":"820774ec-f035-4843-aa1a-764afbc995d1","added_by":"auto","created_at":"2025-11-13 08:48:06","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":14681,"visible":true,"origin":"","legend":"\u003cp\u003eRationality rates of indications for perioperative antimicrobial prophylaxis and combination therapy in Class I surgical incisions\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7894262/v1/999dab7d3e29997c3d0de886.png"},{"id":95807229,"identity":"d1d3d6fc-f461-418e-ab66-4b4d51ff98e1","added_by":"auto","created_at":"2025-11-13 08:48:14","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":14968,"visible":true,"origin":"","legend":"\u003cp\u003eRationality rates of dosage/administration and timing of perioperative antimicrobial prophylaxis in Class I surgical incisions\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7894262/v1/02c268f727a930d7c1a43143.png"},{"id":95807224,"identity":"3bc43de9-abe5-4808-85cd-ad5c13d1d353","added_by":"auto","created_at":"2025-11-13 08:48:14","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":18742,"visible":true,"origin":"","legend":"\u003cp\u003eRationality rates of drug selection and duration for perioperative antimicrobial prophylaxis in Class I surgical incisions\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-7894262/v1/531802425ed29f8992b35623.png"},{"id":95810369,"identity":"18e0f547-b796-4e08-9eea-d9f9f1924a1d","added_by":"auto","created_at":"2025-11-13 08:52:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":521129,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7894262/v1/56833c85-b47f-4f64-be06-256e4b4d27e5.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Practice of a Pharmacy-Led Multidisciplinary Collaborative Closed-Loop Management Model in the Prophylactic Use of Antimicrobial Agents During the Perioperative Period of Orthopedic Class I Incision Surgeries","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe appropriate use of perioperative antimicrobials plays a vital role in preventing surgical site infections, protecting patient safety, and promoting recovery. Standardized antimicrobial administration serves as a fundamental strategy for surgical infection control, influencing both clinical outcomes and public health. Despite its importance, current clinical practices often demonstrate inappropriate antimicrobial use, which contributes to antimicrobial resistance, inefficient resource utilization, and increased healthcare costs, representing a major global challenge in medical quality\u003csup\u003e[1-4]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eSince 2011, the National Health Commission has issued several regulatory documents concerning antimicrobial use management, including the Guidelines for Clinical Application of Antimicrobial Agents\u003csup\u003e\u0026nbsp;[5]\u003c/sup\u003e and the Notice on Continuous Improvement of Clinical Antimicrobial Use Management. These policies have specifically targeted perioperative prophylactic antimicrobial use in Class I incisions as a key focus area for antimicrobial stewardship, aiming to reduce excessive reliance on antimicrobial prophylaxis for surgical site infections. The prophylactic antimicrobial usage rate in Class I incision surgeries has been incorporated as a critical indicator in hospital accreditation evaluations and national healthcare quality assessments, with the objective of promoting standardized and rational clinical antimicrobial use.\u003c/p\u003e\n\u003cp\u003eHowever, clinical practice reveals that excessive and inappropriate perioperative antimicrobial prophylaxis remains prevalent and severe in Class I incision surgeries across China\u003csup\u003e[6]\u003c/sup\u003e. This underscores the urgent need to develop more effective intervention strategies to optimize perioperative antimicrobial use, ensure medication safety, enhance therapeutic efficacy, and improve patient outcomes.\u003c/p\u003e\n\u003cp\u003eCurrently, various models such as the Quality Control Circle (QCC) model\u003csup\u003e[7]\u003c/sup\u003e, Lean Six Sigma method\u003csup\u003e[8]\u003c/sup\u003e, clinical pharmacist intervention\u003csup\u003e[9\u0026ndash;10]\u003c/sup\u003e, Antimicrobial Stewardship (AMS)\u003csup\u003e[11]\u003c/sup\u003e, antimicrobial drug management\u003csup\u003e[12,13]\u003c/sup\u003e, and multidisciplinary team approac \u003csup\u003e[14]\u0026nbsp;\u003c/sup\u003ehave been applied to the management of perioperative antimicrobial agents. However, these approaches exhibit limitations, including significant but unsustainable efficacy, high specialization with limited coverage, and strong systematization but demanding requirements for informatization. A unified model has yet to be established. Although single-intervention models may achieve short-term desired outcomes\u003csup\u003e[15,16]\u003c/sup\u003e, they carry a risk of rebound, indicating the necessity for developing more sustainable management mechanisms.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Second Affiliated Hospital of Zhejiang Chinese Medical University is a tertiary Grade A comprehensive hospital integrating traditional Chinese and Western medicine, with orthopedics as its specialty. Among all Class I incision surgeries, orthopedic procedures account for the highest proportion. Characterized by prolonged operative duration, extended tissue exposure, and lengthy postoperative recovery periods, orthopedic surgeries represent one of the clinical departments with a high incidence of infectious diseases. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBased on the aforementioned background and national policy directives, a multidisciplinary four-dimensional collaborative management framework involving pharmacy, clinical practice, medical administration, and hospital infection control was established. Utilizing the PDCA (Plan-Do-Check-Act) cycle as a closed-loop management pathway, a dual-track mechanism combining information-based implementation monitoring and manual review was implemented. Orthopedic-specific medication evaluation criteria were formulated to statistically investigate the prophylactic use of antimicrobial agents during the perioperative period for Class I incisions in orthopedic surgery. Comparative analyses were conducted across pre-intervention, intervention, and post-intervention phases to evaluate outcomes. This study explored a perioperative antimicrobial management model tailored to Class I incisions in our hospital setting, providing evidence-based support for standardizing prophylactic antimicrobial use and optimizing perioperative management protocols in clinical practice.The research findings hold significant practical value for enhancing the hospital\u0026apos;s refined antimicrobial management system and achieving national health-care quality improvement objectives. Furthermore, this study offers replicable management experience for peer medical institutions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the guidelines of the Helsinki Declaration and was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University of Chinese Medicine on August 5, 2025.(Project Number: 2025-113).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Clinical data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMedical records of all patients undergoing Class I incision surgeries in the Department of Orthopedic from January 2022 to December 2024 were collected. The collected data included:\u003c/p\u003e\n\u003cp\u003eBaseline characteristics (department, name, age, admission date, discharge date),Clinical diagnosis,Allergy history,Surgical details(surgery name, incision classification, operation duration, anesthesia duration),Prophylactic medication (indications, drug selection, dosage and administration, timing of administration, combination therapy, duration of use, etc.).Patients who underwent surgery from January 2022 to June 2022 were assigned to the pre-intervention group, those from July 2022 to June 2023 to the intervention group, and those from July 2023 to December 2024 to the post-intervention group.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e2.1 Establishment of a Pharmacy-Led Multidisciplinary Closed-Loop Management Model\u003c/p\u003e\n\u003cp\u003eA pharmacst-led MDT was formed, integrating clinical departments, infection control, and medical administration.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.1.1 Development of a Pharmacist-Led Pharmaceutical Care Model for Orthopedics\u003c/p\u003e\n\u003cp\u003eClinical pharmacists joined the orthopedic team, participating in ward rounds and assisting in formulating antimicrobial prophylaxis protocols for Class I incision surgeries. They conducted pre-prescription reviews, communicated with clinicians regarding identified issues, and engaged in consultations to promote rational antimicrobial use. Additionally, pharmacists collected comparative data on antimicrobial usage and SSI rates from peer institutions to guide clinical decisions. A proactive pharmaceutical care model was established, encompassing clinical rounds, patient assessment, antimicrobial regimen optimization, prescription review, pharmaceutical monitoring, and consultation. This transition from reactive to proactive pharmaceutical services enhanced clinicians' awareness of rational antimicrobial use.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.1.2 Implementation of a Multidisciplinary Closed-Loop Management System\u003c/p\u003e\n\u003cp\u003eAn MDT involving pharmacy, clinical departments, medical administration, and infection control was formed. Pharmacists collaborated with clinicians to develop evaluation criteria for perioperative antimicrobial use in Class I incisions. Prescription reviews were intensified, with results reported to the medical administration and publicly disclosed on the hospital’s intranet. Regular updates on antimicrobial use, particularly for underperforming medical teams, were provided during hospital-wide meetings. The infection control department conducted preoperative antimicrobial usage audits and provided feedback to clinicians. Joint quality inspections by pharmacy and medical administration focused on perioperative antimicrobial use, with findings publicly reported. Clinicians with inappropriate prescribing practices were counseled by medical administration. Antimicrobial stewardship metrics were incorporated into departmental performance evaluations, influencing physician assessments, promotions, and commendations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.1.3 Optimization of the Antimicrobial Stewardship Formulary\u003c/p\u003e\n\u003cp\u003eThe absence of cefazolin and clindamycin in the hospital’s formulary limited prophylactic options for Class I incisions. Pharmacists conducted a reevaluation of existing antimicrobials, identifying redundant, low-efficacy, high-resistance, or high-adverse-effect agents with insufficient evidence-based support. Optimization proposals were submitted to the Antimicrobial Stewardship Working Group and the Pharmacy and Therapeutics Committee. Following deliberation, cefazolin and clindamycin were successfully added, refining the hospital’s antimicrobial classification and management system.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.1.4 Development of a Training and Evaluation System for Antimicrobial Agents \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe have established a pyramid-shaped antimicrobial agent training and assessment system, structured as follows:\u003c/p\u003e\n\u003cp\u003e- Base Level: Hospital-wide training and assessment.\u003c/p\u003e\n\u003cp\u003e- Middle Level: Department-specific training.\u003c/p\u003e\n\u003cp\u003e- Apex: Case review sessions focusing on orthopedic.\u003c/p\u003e\n\u003cp\u003eRegular offline and online sessions, lectures, and academic salons covered rational perioperative antimicrobial use and formulary management. Educational materials, including “Guidelines for Rational Antimicrobial Use” and “Xinhua Pharmacy Bulletin” summarized evidence-based recommendations for orthopedic perioperative prophylaxis. Clinical pharmacists conducted one-on-one departmental training, tailoring content to surgical types and patient conditions. The multidisciplinary team goes to orthopedic wards to conduct surgical case - analysis meetings, discusses irrational drug - use cases, and offers references for other departments to promote the proper use of antimicrobial drugs. After training, doctors must pass relevant assessments to obtain the prescribing qualifications for corresponding antimicrobial drugs.\u003c/p\u003e\n\u003cp\u003e2.1.5 Enhancement of the Surgical Prophylaxis Information System\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn intelligent prescribing system was integrated into the electronic order system, enabling real-time access to drug monographs. For Class I incisions, the system utilized rule-based algorithms to assess indications and recommend standardized prophylactic regimens. Alerts were triggered for non-compliant orders, restricting further actions to reduce inappropriate selections. Dosage and administration limits were enforced. Preoperative antimicrobial administration was monitored via personal digital assistant (PDA) scanning by surgical nurses, recording precise start and end times to ensure administration within 0.5–1 hour before incision. An automatic stop-order system prevented prolonged courses due to delayed discontinuation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.2 Statistical Methods\u003c/p\u003e\n\u003cp\u003eData analysis was performed using SPSS 26.0.Continuous variables were expressed as mean\u0026nbsp;\u003cimg width=\"6\" height=\"16\" src=\"data:image/png;base64,R0lGODlhBgAQAHcAMSH+GlNvZnR3YXJlOiBNaWNyb3NvZnQgT2ZmaWNlACH5BAEAAAAALAAABAAGAAkAhAAAAAAAAAAAOgAAZgA6ZgA6kABmtjo6ADqQ22YAAGY6AGa2/5A6ALZmALb//9uQOtv///+2Zv//tv//2wECAwECAwECAwECAwECAwECAwECAwECAwECAwECAwECAwECAwUlYBKMwQCc6FNAQINMDBINDhAJx3LC6xkRCgRAkljMHA/DqWEIAQA7\" alt=\"image\"\u003e±s, and comparisons among multiple groups were conducted using one-way analysis of variance (ANOVA).Categorical variables were presented as counts or percentages and analyzed using the χ² test,P-value \u0026lt; 0.05 was considered statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e3.1. General Patient Characteristics\u003c/p\u003e\n\u003cp\u003eA total of \u0026nbsp;2,381 orthopedic patients undergoing Class I incision surgerieswere enrolled from January 2022 to December 2024. No statistically significant differences were observed among the three groups in terms of gender and age (Table 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 1 General information of patients with Type I incision surgery\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"580\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 136px;\"\u003e\n \u003cp\u003eGroup\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 116px;\"\u003e\n \u003cp\u003eNumber of Cases\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e/n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 187px;\"\u003e\n \u003cp\u003eGender/n\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 140px;\"\u003e\n \u003cp\u003eAge/years\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003ePre-intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 116px;\"\u003e\n \u003cp\u003e352\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e152\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e200\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 140px;\"\u003e\n \u003cp\u003e60.36\u0026plusmn;18.56\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eDuring-intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 116px;\"\u003e\n \u003cp\u003e851\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e378\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e473\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 140px;\"\u003e\n \u003cp\u003e62.55\u0026plusmn;17.79\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003ePost-intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 116px;\"\u003e\n \u003cp\u003e1178\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e464\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 93px;\"\u003e\n \u003cp\u003e714\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 140px;\"\u003e\n \u003cp\u003e61.44\u0026plusmn;17.76\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e3.2. Distribution of class I Incision Surgical Procedures and Antimicrobial Prophylaxis Utilization Rate\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe orthopedic Type I incision surgeries primarily included internal fixation, balloon kyphoplasty for thoracic/lumbar vertebral fractures, cervical/thoracic/lumbar spinal fusion, joint replacement, arthroscopic joint repair, ligament repair, and removal of internal fixation devices. The preoperative antimicrobial prophylaxis rate for orthopedic Type I incisions was 60.51% before the intervention, 59.17% during the intervention, and 51.71% after the intervention, with statistically significant differences (P \u0026lt; 0.05)（Figure 1）.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3.3.Evaluation of Rationality Indicators for Perioperative Antimicrobial Prophylaxis in Orthopedic Type I Incision Surgeries\u003c/p\u003e\n\u003cp\u003eIndications for Prophylactic Use:Antimicrobial prophylaxis is indicated for Type I incision surgeries involving implant placement (e.g., internal fixation, artificial joint replacement) or spinal-related procedures, whereas it is generally unnecessary for procedures such as removal of internal fixation devices. \u0026nbsp;The compliance rate was 94.37% before the intervention, 94.48% during the intervention, and 95.87% after the intervention, with no statistically significant difference (P\u0026gt;0.05).Combination Therapy:Single-agent antimicrobial prophylaxis is recommended for Type I incisions, without the need for combination therapy. The compliance rate for combination therapy improved from 96.24% before the intervention to 96.45% during the intervention and further to 99.84% after the intervention, with statistically significant differences (P \u0026lt; 0.05)（Figure 2）.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDosage and Administration: The prophylactic antimicrobial dosage should comply with the drug Instructions and antimicrobial guidelines. The compliance rate increased from 83.57% before the intervention to 88.76% during the intervention and reached 100% after the intervention. The optimal timing for prophylactic administration is 0.5~1 hour before skin or mucosal incision or at the initiation of anesthesia. The compliance rate for administration timing improved from 81.69% before the intervention to 86.79% during the intervention and further to 90.32% after the intervention, with statistically significant differences (P \u0026lt; 0.05)（Figure 3）.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAntimicrobial Selection: First- and second-generation cephalosporins should be the primary choice for antimicrobial prophylaxis in orthopedic Type I incision surgeries. The compliance rate increased from 61.03% before the intervention to 72.98% during the intervention and further to 97.46% after the intervention. Duration of Prophylaxis: The prophylactic antimicrobial course for Type I incision surgeries should not exceed 24 hours. The compliance rate improved from 12.68% before the intervention to 41.62% during the intervention and further to 71.43% after the intervention, with statistically significant differences (P \u0026lt; 0.05)（Figure 4）.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eClass I incision surgeries involve uncontaminated sites without involvement of respiratory, digestive, or other body cavities communicating with the external environment, and thus typically do not require prophylactic antimicrobial agents. Since the national antimicrobial stewardship campaign was launched, healthcare institutions at all levels have implemented multiple proactive measures to promote rational antimicrobial use. As a traditional Chinese and Western medicine hospital with a strong orthopedic specialty, our institution performs a high volume of orthopedic surgeries. Consequently, perioperative prophylactic antimicrobial use in clean surgeries has been a key focus of management. Investigations revealed several irrational prescribing practices, including unclear indications for antimicrobial prophylaxis, inappropriate drug selection, improper timing of administration, and excessively prolonged duration of use\u0026mdash;with the most prominent issue being unnecessarily prolonged prophylactic courses.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo address these problems, this study established a closed-loop management model led by pharmacy and supported by a multidisciplinary team. This model centers on monitoring dynamic changes in rationality indicators, integrating corrective measures with continuous quality improvement to optimize perioperative prophylactic antimicrobial use in Class I incision surgeries.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough antimicrobial prophylaxis is generally unnecessary for Class I surgical wounds, it may be considered in cases involving extensive surgical fields, prolonged operative durations, critical organ involvement, foreign body implantation, or high-risk factors for infection (e.g., advanced age, diabetes, immunocompromised status, or malnutrition). According to relevant evaluation criteria, the prophylactic antimicrobial use rate should not exceed 30%. However, our findings indicate that the prophylactic use rate in orthopedic Class I surgical wounds exceeded this target both before and after the implementation of this model. This discrepancy primarily stems from the nature of orthopedic procedures at our institution, which predominantly involve internal fixation, joint replacement, artificial femoral head replacement (all involving foreign body implantation), and spinal surgeries (with or without implants). These procedures are characterized by extensive surgical fields, prolonged durations, and inherent infection risks, justifying antimicrobial prophylaxis. Additionally, our patient population includes a high proportion of elderly individuals (40.7% aged \u0026gt;70 years), who often exhibit reduced immunity and multiple comorbidities, further elevating infection risks and contributing to higher prophylactic use rates compared to other departments performing Class I surgeries. Nevertheless, some cases lacked clear indications for prophylaxis, such as internal fixation removal in patients without additional risk factors, where antimicrobial prophylaxis is typically unnecessary. For instance, arthroscopic rotator cuff repair\u0026mdash;a common shoulder procedure\u0026mdash;has been shown not to increase the incidence of superficial or deep shoulder infections when performed without antimicrobial prophylaxis \u003csup\u003e[17]\u003c/sup\u003e. Thus, unless foreign body implantation is involved, antimicrobial prophylaxis is unnecessary for this procedure.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe most common pathogens in orthopedic surgical site infections (SSIs) are Gram-positive bacteria, particularly Staphylococcus aureus. First- and second-generation cephalosporins are the preferred prophylactic agents, with vancomycin (or norvancomycin) and clindamycin recommended for patients with cephalosporin allergies. Our pre-intervention data revealed irrational antimicrobial selection, predominantly involving cefoxitin, ceftriaxone, cefotaxime, isepamicin, and fluoroquinolones, with cephalosporins and third-generation cephalosporins accounting for 83% of inappropriate selections. Robust evidence underscores the importance of standardized antimicrobial selection: in orthopedic arthroplasty, first-generation cephalosporins significantly reduce periprosthetic joint infection rates compared to non-first-generation alternatives such as vancomycin or clindamycin \u003csup\u003e[18]\u003c/sup\u003e. A retrospective study on perioperative prophylaxis in hip and knee arthroplasty further demonstrated that non-cefazolin regimens (e.g., vancomycin, clindamycin, or others) were associated with an increased risk of SSIs \u003csup\u003e[19]\u003c/sup\u003e. Additionally, clinical observations indicate that patients with cephalosporin allergies who receive alternative prophylactic agents exhibit significantly higher SSI rates, particularly deep infections \u003csup\u003e[20]\u003c/sup\u003e. These findings highlight the critical role of rational antimicrobial selection in postoperative infection control. Strict adherence to antimicrobial selection principles is essential for reducing infection risks and enhancing surgical safety. Post-intervention, the rational antimicrobial selection rate reached 94.93%.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIntravenous administration 0.5~1 hour before incision ensures adequate tissue drug concentrations during the critical period of surgical contamination, effectively reducing postoperative infections. Administration too early may result in subtherapeutic drug levels during the contamination phase, while delayed administration misses the optimal window for bacterial colonization control, increasing infection risks. Studies demonstrate that patients receiving antimicrobials \u0026gt;1 hour before lumbar fusion surgery exhibit significantly higher SSI rates \u003csup\u003e[21]\u003c/sup\u003e. Our investigation identified cases where preoperative administration occurred \u0026lt;30 minutes or \u0026gt;1 hour before incision, likely due to scheduling challenges in sequential surgeries. Some patients received no preoperative prophylaxis, with antimicrobials initiated postoperatively in the ward. Additionally, intraoperative redosing was omitted in procedures lasting \u0026gt;3 hours or with blood loss exceeding 1500 ml, possibly reflecting knowledge gaps among surgeons. These issues improved significantly following model implementation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eExcessively prolonged prophylactic durations remain the most common problem in perioperative antimicrobial use for orthopedic Class I wounds. Guidelines recommend prophylaxis not exceeding 24 hours. Although surgeons may prolong antimicrobial use due to concerns about SSIs leading to surgical failure, extended durations do not reduce infection risks but instead contribute to bacterial resistance, adverse effects, and increased financial burdens. Through this management model, the rational duration rate improved from 12.68% to 71.43%, though further optimization is needed. Future enhancements include electronic system refinements, such as defaulting prophylactic antimicrobial orders to one-time or 24-hour prescriptions to prevent inadvertent prolongation due to overlooked discontinuation orders.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe implementation of a pharmacy-led, multidisciplinary collaborative closed-loop management model, characterized by efficient interdisciplinary cooperation and proactive engagement, is essential for successful promotion and execution. The application of this model has significantly improved the rational use of perioperative prophylactic antibiotics for Class I incisions in orthopedics, particularly in optimizing drug selection, timing of administration, and duration of treatment. By integrating pharmacists into the clinical workflow, implementing real-time informatics-based feedback, and conducting multidisciplinary joint supervision, a dynamic intervention system has been established. This approach provides a replicable management pathway for peer institutions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLimitations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e① This model has demonstrated partial efficacy in reducing both the utilization rate and rational use rate of perioperative prophylactic antibiotics for Class I incision patients in the orthopedic department. However, it has not yet met the requirement (\u0026lt;30% prophylactic antibiotic use rate for Class I incision surgeries) specified in the evaluation criteria for tertiary integrated traditional Chinese and Western medicine hospitals. Significant room for improvement remains, particularly regarding treatment duration. Subsequent interventions could incorporate experiences from other institutions by: (a) strengthening clinical pharmacists' leadership role, (b) establishing department-specific antibiotic use pathways for orthopedics, and (c) implementing daily postoperative medication indication assessment protocols to achieve refined antibiotic management.\u003c/p\u003e\n\u003cp\u003e② As a single-center study, the generalizability of findings may be limited by inclusion criteria and geographical constraints, potentially affecting the representativeness of the patient population's disease characteristics. Future multicenter real-world studies should incorporate data from hospitals across different regions and tiers, while employing stratified approaches to control confounding factors (e.g., surgical types, underlying diseases) to enhance the external validity of conclusions.\u003c/p\u003e\n\u003cp\u003e③ While administrative interventions currently play a pivotal role in this model, their sustainability remains challenging. Key strategies include: (a) institutionalizing temporary measures as core hospital protocols, (b) expanding the framework to encompass all surgical incision types hospital-wide based on institutional realities, and (c) progressively covering all surgical categories to standardize perioperative antibiotic use and management. This model provides empirical evidence for antibiotic stewardship in integrated traditional Chinese and Western medicine hospitals. Subsequent research should incorporate health economic evaluations (e.g., cost-benefit analyses) to further validate its scalability. Concurrently, the integration with Diagnosis-Related Groups (DRG) payment reforms could incorporate rational medication metrics into performance evaluation systems, achieving tripartite optimization among administration, clinical practice, and healthcare financing.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the guidelines of the Helsinki Declaration and was approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University of Chinese Medicine on August 5, 2025.(Project Number: 2025-113).The ethics committee granted a waiver of informed consent for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent for publication is not applicable as this manuscript does not contain any individual person's data in any form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the data and supportive information are provided within the article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of conflicting interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no conflict of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was not supported by any funding.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors have contributed to the design and conceptualization of the research. Research selection, data collection, data analysis, and contact with authors included in the study to obtain more information were conducted by M, Y, N, Z, and R. M drafted this paper. Z further revised the text. The final version of this article has been reviewed and approved by M, Y, N, Z, and R.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003cstrong\u003e：\u003c/strong\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eEckmann C, Aghdassi SJS, Brinkmann A, et al. Perioperative Antibiotic Prophylaxis\u0026mdash;Indications and Modalities for the Prevention of Postoperative Wound Infection. Dtsch Arztebl Int. 2024 Apr 5;121(7):233-242. \u003c/li\u003e\n\u003cli\u003eSantoshi JA, Behera P, Nagar M, et al. Current Surgical Antibiotic Prophylaxis Practices: A Survey of Orthopaedic Surgeons in India. Indian J Orthop. 2020 Nov 18;55(3):749-757. \u003c/li\u003e\n\u003cli\u003eMwita JC, Ogunleye OO, Olalekan A, et al. Key Issues Surrounding Appropriate Antibiotic Use for Prevention of Surgical Site Infections in Low- and Middle-Income Countries: A Narrative Review and the Implications. Int J Gen Med. 2021 Feb;14:515-530.\u003c/li\u003e\n\u003cli\u003eNagata K, Yamada K, Shinozaki T, et al. Effect of Antimicrobial Prophylaxis Duration on Health Care-Associated Infections After Clean Orthopedic Surgery: A Cluster Randomized Trial. JAMA Netw Open. 2022 Apr;5(4):e226095.\u003c/li\u003e\n\u003cli\u003eRevised Working Group of the Guidelines for Clinical Application of Antimicrobial Agents. Guidelines for Clinical Application of Antimicrobial Agents [M]. Beijing: People\u0026apos;s Medical Publishing House, 2015. \u003c/li\u003e\n\u003cli\u003eFesus A, Benko R, Matuz M, et al. The Effect of Pharmacist-Led Intervention on Surgical Antibacterial Prophylaxis (SAP) at an Orthopedic Unit. Antibiotics (Basel). 2021 Dec 9;10(12):1509. \u003c/li\u003e\n\u003cli\u003eGuo W Y, Lv J, WangY J, et al. Effect evaluation of PDCA cycle on prophylactic use of antimicrobial agents in type I incision surgery of ophthalmology department[J]. Chin J Med Guide, 2020, 22(4): 270-274. \u003c/li\u003e\n\u003cli\u003eYang Y. Application of Lean Six Sigma Methodology in Antimicrobial Stewardship for Class I Incisions in Traditional Chinese Medicine Hospitals [D]. Hubei University of Science and Technology, 2020:7. \u003c/li\u003e\n\u003cli\u003eWu D, Li Y, Zhen J, et al. Effectiveness analysis of a pharmacist-led intervention for orthopedic perioperative use of antibiotics: a retrospective cohort study. Front Pharmacol. 2024 Nov 14;15:1365370. \u003c/li\u003e\n\u003cli\u003eZhou H, Liu L, Sun X, et al. The impact of pharmacist intervention on prophylactic antibiotics use in orthopedic surgery at a hospital in China. Medicine (Baltimore). 2021 Dec 30;100(52):e28458. \u003c/li\u003e\n\u003cli\u003eSegala FV, Murri R, Taddei E, et al. Antibiotic appropriateness and adherence to local guidelines in perioperative prophylaxis: results from an antimicrobial stewardship intervention. Antimicrob Resist Infect Control. 2020 Oct 26;9(1):164. \u003c/li\u003e\n\u003cli\u003eJones R, Quartuccio KS, Stern JL, Heintz EV, Pillinger KE, Myers TG. Antibiotic Stewardship Interventions Improve Choice of Antibiotic Prophylaxis in Total Joint Arthroplasty in Patients with Reported Penicillin Allergies. Clin Orthop Relat Res. 2021 Jul 1;479(7):1484-1494. \u003c/li\u003e\n\u003cli\u003eMaher M, Ward A, Ward K, et al. Minimizing the Risk of Surgical Site Infection Following Hip Fracture Operation. Surg Infect (Larchmt). 2024 Oct;25(8):574-579. \u003c/li\u003e\n\u003cli\u003eWang A, Qin K, Ma S. Improving Antimicrobial Utilization and Infection Control in Ophthalmology: An Information-Assisted Transparent Supervision and Multidisciplinary Team Model. Infect Drug Resist. 2024 Nov 13;17:5061-5072. \u003c/li\u003e\n\u003cli\u003eGoycochea-Valdivia WA, Melendo P\u0026eacute;rez S, Aguilera-Alonso D, et al. Position statement of the Spanish Society of Paediatric Infectious Diseases on the introduction, implementation and assessment of antimicrobial stewardship programmes in paediatric hospitals. An Pediatr (Engl Ed). 2022 Nov;97(5):351.e1-351.e12. \u003c/li\u003e\n\u003cli\u003eVo C, Geoffrion AV, Mohamed ZA, Morin JN, et al. Impact of individualized feedback letters on adherence to surgical antibiotic prophylaxis guidelines: an interrupted time series study (FEEDBACK-ASAP). Am J Infect Control. 2023 Apr;51(4):440-445. \u003c/li\u003e\n\u003cli\u003eBaraza N, Simon MJK, Leith JM. Arthroscopic rotator cuff repair without antibiotic prophylaxis does not increase the infection rate. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):3956-3960. \u003c/li\u003e\n\u003cli\u003eMarigi EM, Bartels DW, Yoon JH, Sperling JW, Sanchez-Sotelo J. Antibiotic Prophylaxis with Cefazolin Is Associated with Lower Shoulder Periprosthetic Joint Infection Rates Than Non-Cefazolin Alternatives. J Bone Joint Surg Am. 2022 May 18;104(10):872-880. \u003c/li\u003e\n\u003cli\u003eZastrow RK, Huang HH, Galatz LM, et al. Characteristics of Antibiotic Prophylaxis and Risk of Surgical Site Infections in Primary Total Hip and Knee Arthroplasty. J Arthroplasty. 2020 Sep;35(9):2581-2589.\u003c/li\u003e\n\u003cli\u003eNiu T, Zhang Y, Li Z, et al. The association between penicillin allergy and surgical site infection after orthopedic surgeries: a retrospective cohort study. Front Cell Infect Microbiol. 2023 Apr 21;13:1182778. \u003c/li\u003e\n\u003cli\u003eCanseco JA, Karamian BA, DiMaria SL, et al. Timing of Preoperative Surgical Antibiotic Prophylaxis After Primary One-Level to Three-Level Lumbar Fusion. World Neurosurg. 2021 Sep;153:e349-e358. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Pharmacy-Led, Multidisciplinary collaboration, Closed-loop management, Orthopedic Class I Incision Surgeries, Prophylactic use","lastPublishedDoi":"10.21203/rs.3.rs-7894262/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7894262/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective: \u003c/strong\u003eTo evaluate the efficacy of a pharmacy-led multidisciplinary collaborative closed-loop management model in improving the rational use of perioperative prophylactic antimicrobial agents in orthopedic Class I incision surgeries.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eA pharmacy-led multidisciplinary collaborative closed-loop management model involving pharmacy, clinical departments, medical administration, and hospital infection control was established to address irrational prophylactic antimicrobial use in orthopedic Class I incision surgeries at our hospital. Medical records of all patients undergoing Class I incision surgeries in the orthopedic department from January 2022 to December 2024 were retrospectively reviewed. The intervention effects were assessed by comparing six key aspects before and after implementation: indications for antimicrobial use, drug selection, timing of administration, dosage and frequency, combination therapy, and duration of prophylaxis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRseults: \u0026nbsp;\u003c/strong\u003eFollowing the intervention, the prophylactic antimicrobial use rate decreased from 60.51% to 53.48% (P\u0026lt; 0.05). The compliance rate for appropriate indications increased from 94.37% to 95.87% (P\u0026gt; 0.05). The rational drug selection rate improved from 61.03% to 97.46% (P \u0026lt; 0.05). The rational dosage and frequency rate rose from 83.57% to 100% (P \u0026lt; 0.05). The rational combination therapy rate increased from 96.24% to 99.84% (P \u0026lt; 0.05). The compliance rate for optimal timing of administration improved from 81.69% to 90.32%, and the rational duration of prophylaxis increased from 12.68% to 71.43% (P \u0026lt; 0.05).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion: \u003c/strong\u003eThe pharmacy-led multidisciplinary collaborative closed-loop management model effectively enhances the rational use of perioperative prophylactic antimicrobial agents in orthopedic Class I incision surgeries, demonstrating high feasibility and broad applicability.\u003c/p\u003e","manuscriptTitle":"Practice of a Pharmacy-Led Multidisciplinary Collaborative Closed-Loop Management Model in the Prophylactic Use of Antimicrobial Agents During the Perioperative Period of Orthopedic Class I Incision Surgeries","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-13 07:58:01","doi":"10.21203/rs.3.rs-7894262/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"133182737080918336473850730738261079213","date":"2025-12-26T15:49:56+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-11-02T13:06:55+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-31T06:38:48+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-30T06:31:16+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-30T06:30:15+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Musculoskeletal Disorders","date":"2025-10-18T14:53:11+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c8c5c61d-561b-4e91-b8a0-f60c1ba0e351","owner":[],"postedDate":"November 13th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-11-13T07:58:01+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-13 07:58:01","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7894262","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7894262","identity":"rs-7894262","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}