Clinical Equivalence of Polyglycolic Acid Suture and Polyglactin 910 Suture for Subcutaneous Tissue Closure After Cesarean Delivery: A Single-Blind Randomized Study

Abstract

Purpose 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.

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

“…Secondary endpoints included incidence of subcutaneous abdominal wound disruptions (within 12 weeks of cesarean delivery), skin disruption (spontaneous or iatrogenic separation of the wound edges of at least 1 cm in width), superficial/deep SSI [ 12 ], hematoma and seroma (collection of blood or serous fluid around the wound, respectively), suture removal, microbial deposits on sutures (in case of infection), intraoperative handling, operative time (skin incision to closure), hospital stay, time taken to return to normal activities, pain with visual analog scale (VAS), and adverse events. A five-point scale was used to rate the suture handling characteristics, viz.…”

“…ease of passage through tissue, first-throw knot holding, knot tie-down smoothness, knot security, stretch capacity, memory, and suture fraying. Ratings of 1, 2, 3, 4, and 5 indicated poor, fair, good, very good, and excellent suture handling characteristics, respectively [ 12 ]. In addition, other suture-related challenges were recorded.…”

“…In addition, other suture-related challenges were recorded. The postoperative pain, severe, moderate, mild, and no pain, was specified by 75-100, 45-74, 5-44, and 0-4 VAS, respectively [ 12 ]. During the study period, the occurrence of any untoward medical or clinical sign, or unintended disease/injury, which was already reported as the study endpoint, was not labeled and reported as an adverse event.…”