Medical Devices: Evidence and Research (Jan 2023)
Clinical Equivalence of Polyglycolic Acid Suture and Polyglactin 910 Suture for Subcutaneous Tissue Closure After Cesarean Delivery: A Single-Blind Randomized Study
Abstract
CH R Vasundara Devi,1 Rathindranath Ray,2 Sindhu Koduri,1 Ashok Kumar Moharana,3 Deepak TS3 1Department of Obstetrics and Gynaecology, KIMS Hospital, Secunderabad, Telangana, India; 2Department of Obstetrics and Gynaecology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India; 3Department of Clinical Affairs, Healthium Medtech Limited, Bangalore, Karnataka, IndiaCorrespondence: Rathindranath Ray, Department of Obstetrics and Gynaecology, IPGMER and SSKM Hospital, Kolkata, West Bengal, India, Tel +91 9831286320, Email [email protected]: The global rise in frequency of cesarean delivery raises the concern to minimize the post-operative complications, in order to improve the maternal and neonatal health. Closure of subcutaneous tissue following cesarean section closes dead space, hence reduces the wound complications. No previous study has compared the clinical equivalence of polyglycolic acid suture with polyglactin 910 suture for subcutaneous tissue closure following cesarean section. Therefore, this study compared the incidence of subcutaneous abdominal wound disruptions within the first 6 weeks of subcutaneous tissue closure with either of the sutures.Patients and Methods: A single-blind, prospective, randomized study was conducted in two centres between February and November, 2021. Primiparous or multiparous women (18– 40 years) with a singleton pregnancy requiring cesarean section were randomized to polyglycolic acid suture (Truglyde®) (n=54) and polyglactin 910 suture (Vicryl®) (n=54) group. The primary endpoint, incidence of subcutaneous abdominal wound disruptions within 6 weeks of cesarean delivery was evaluated. In addition, the secondary endpoints, incidence of post-operative subcutaneous abdominal wound disruptions for the study period, skin disruption, surgical site infection (SSI), seroma, hematoma, intraoperative handling, operative time, hospital stay, suture removal, microbial deposits on sutures, pain, time taken to resume normal activities, and adverse events were recorded.Results: Non-significant difference in the incidence of subcutaneous abdominal wound disruptions, skin disruption, SSI, seroma, hematoma, intraoperative handling characteristics, operative time, pain, duration of hospital stay, suture removal, microbial deposits, time taken to return to day-to-day activities, and adverse events were observed between the two treatment groups.Conclusion: Following cesarean section, subcutaneous tissue closure using polyglycolic acid suture or polyglactin 910 suture was not associated with incidence of subcutaneous abdominal wound disruptions. Additionally, non-significant differences regarding secondary endpoints between the groups suggested the clinical equivalence of the sutures.CTRI Registration Number: CTRI/2020/12/029737; Registration date: 11/12/2020.Keywords: abdominal wound disruption, cesarean delivery, polyglactin 910 sutures, polyglycolic acid sutures
