Clinical Equivalence of Trusynth® and Vicryl® Polyglactin 910 Sutures for Subcutaneous Tissue Closure During Cesarean Delivery: A Single-Blind Randomized Controlled Trial.

Abstract

Background Post-cesarean complications such as surgical site infection (SSI), bleeding, and dehiscence may occur after cesarean delivery. Subcutaneous tissue closure will reduce these complications. With this background, this study assessed the clinical equivalence of Trusynth® and Vicryl® polyglactin 910 sutures for subcutaneous tissue closure. Methods In this randomized, single-blind study (from January 5, 2021 to December 24, 2021), a total of 113 women with a singleton pregnancy scheduled for cesarean section were included in the study and randomized to Trusynth® (n=57) and Vicryl® (n=56) group. The primary endpoint was the incidence of subcutaneous abdominal wound disruption within six weeks of cesarean delivery. The secondary endpoints included postoperative complications (SSI, hematoma, seroma, and skin disruptions), operative time, intraoperative handling characteristics, postoperative pain, hospital stay, time taken to return to normal activities, suture removal, microbial deposits on sutures, and adverse events. Results No incidence of subcutaneous abdominal wound disruption was recorded. Non-significant differences in intraoperative handling parameters (except memory, p=0.007), postoperative pain, skin disruption, SSI, hematoma, seroma, hospital stay, and time to return to normal activities were observed between Trusynth® and Vicryl® groups. Conclusion Both Trusynth® and Vicryl® polyglactin 910 sutures can be regarded as clinically equivalent. These are safe and effective for subcutaneous tissue closure during cesarean section with minimal risk of subcutaneous abdominal wound disruptions.