Randomized Trial of Antimicrobial-Coated Sutures To Prevent Surgical Site Infection after Breast Cancer Surgery

Background: Surgical site infection (SSI) is the fourth commonest healthcare-associated infection and complicates at least 5% of open operations. In a randomized clinical trial, antimicrobial-coated sutures were compared with their conventional counterparts, polyglactin and poliglecaprone, for skin closure after breast cancer surgery to assess their role in reducing the rate of SSI. Methods: Between November 2008 and February 2011, 150 female patients presenting with breast cancer to a single center were randomized to skin closure with antimicrobial-coated or plain sutures. Postoperatively, SSI was defined using the U.S. Centers for Disease Control and Prevention (CDC) definitions and scored using the ASEPSIS or Southampton systems by trained, blinded observers with close post-discharge surveillance and patient diaries. Surgeons and patients were blinded to the type of suture used. Results: Using CDC criteria, the overall rate of SSI was 18.9% at six weeks. Six patients (4.7%) needed intervention or readmission for SSI. Skin closure with antimicrobial sutures showed a non-statistically significant reduction in the SSI rate, to 15.2%, compared with conventional sutures (22.9%). A uniform tendency for fewer SSIs in the antimicrobial-coated suture group was found using ASEPSIS and Southampton scores, but again, the difference was not statistically significant. Conclusion: The previously reported high rate of SSI related to breast surgery was confirmed. Using statistical modeling and earlier reports, the study was powered to show a difference using ASEPSIS scores, but the modification used in this trial failed to find a difference. Finding a statistically significant difference would have needed two to three times the number of patients recruited. Further evaluation of antimicrobial-coated sutures is merited, particularly if used as part of a care bundle to reduce SSI after breast cancer surgery.