Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Simultaneous Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial Protocol.

INTRODUCTION:Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. After the completion of the surgical procedure, the skin closure is done. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e., polypropylene (Prolene) sutures or the skin staple sutures. There are no standard guidelines as which type of the suture should be used. The present study aims to compare the incidence of surgical site infections (superficial and deep) for Prolene vs staple sutures in the bilateral knee arthroplasty patients within 6 weeks for superficial and within 90 days for deep infection. METHODS:This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be selected and randomized in 1:1 ratio to receive either of the two interventions i.e., Prolene or Staples. Patients undergoing unilateral or staged total knee replacement (TKR) were excluded. ANALYSIS:The normality assessment will be done using Shapiro Wilk test. Cox proportional hazard regression will be used to check the univariate and multi-variable associations of independent variables with the outcome. Both intention to treat analysis and per protocol analysis would be performed. ETHICS AND DISSEMINATION:All the required approvals will be taken from the ethical review committee. Informed consent will be taken form the patient to enroll him/her in the study. Results of the study will be disseminated to the study participants, public health and clinical professionals and would also be published in a reputable international journal.The trial is registered at clinicaltrials.gov and UIN of the registry is NCT04492852. HIGHLIGHTS:Post-operative surgical site infections and complications are a major concern nowadays.Skin staples are not widely used as compared to Prolene because they are expensive and not easily available in every hospital.There are no standard guidelines as which type of the suture should be used.The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure.