A single-blind randomised controlled trial comparing clinical equivalence of Trulon® and Ethilon® polyamide sutures for the skin closure following laparotomy incisions

Abstract

BackgroundLaparotomy is a common procedure to gain access to the peritoneal cavity, for obstetrics, gynecological, and digestive system-related surgeries. Wound infection is among other complications of laparotomy. This study compared the rate of wound infection post-laparotomy skin closure using Trulon® and Ethilon® polyamide sutures. MethodsThis multicentric, prospective, two-arm, parallel-group, randomized (1:1), single-blind study (CTRI/2020/09/027978) was conducted between January and July 2021, and included 102 women undergoing laparotomy-based obstetric/gynecological procedures. The primary endpoint, incidence of wound infection [superficial and deep surgical site infection(SSI)] occurring within 12 weeks of the surgery was compared between two treatment groups, Trulon® (n = 50) and Ethilon® (n = 52). The secondary endpoints, incidence of wound dehiscence, suture sinus, seroma, hematoma, skin disruption, suture loosening, re-suturing, duration of surgery, suture removal, hospital stay, intraoperative suture handling parameters, pain score, return to normal day-to-day activities, modified Hollander cosmesis score, subject satisfaction score, and adverse events were also evaluated. ResultsNon-significant differences were observed in the incidence of SSI, wound dehiscence, suture sinus, seroma, hematoma, skin disruption, suture loosening, re-suturing, intraoperative handling parameter (except ease of passage), operative time, hospital stay, suture removal duration, pain score, time to return to day-to-day activities, modified Hollander cosmesis score, and subject satisfaction score between the two groups. ConclusionTrulon® and Ethilon® polyamide sutures are clinically equivalent. For abdominal skin closure following laparotomy both the sutures deliver a lower chance of infection, minimal pain, higher satisfaction, and cosmesis score. Registration of researchThis trial is registered prospectively at Clinical Trial Registry of India (CTRI Reg. No: CTRI/2020/09/027978; Registered on: 23/09/2020).