Clinical Equivalence of Monoglyde® and Monocryl® Absorbable Poliglecaprone-25 Sutures: A Single-Blind, Randomized Study

Abstract

Objectives: Poliglecaprone-25 is a synthetic monofilament suture, commonly used for post-cesarean subcuticular skin closure. The present study was designed to assess the effect of subcuticular skin closure using Monoglyde® vs. Monocryl® poliglecaprone-25 absorbable sutures, on the risk of wound composite outcomes in the first 30 days postpartum [surgical site infection (SSI), wound dehiscence, hematoma or seroma]. Study Design: This is a prospective, single-blind, randomized (1:1), multicentric, two-arm, study performed between September 2020 and December 2021 at two different centres across India. Women (18-40 years) with a singleton pregnancy, requiring cesarean delivery were randomized to Monoglyde® (n=62) or Monocryl® (n=62) suture groups. The primary endpoint is incidence of wound composite outcomes in the first 30 days postpartum (SSI, wound dehiscence, seroma, or hematoma). In addition, the secondary outcomes, incidence of wound composite outcome at all visits (till 4 months), suture extrusion and loosening, suture removal and evaluation of microbial deposits on sutures (in case not absorbed or infection), operative time, intraoperative suture handling, postoperative pain, return to normal day-to-day activities, modified Hollander cosmesis score, subject satisfaction score, and adverse events were noted. Results: Non-significant difference between the groups regarding demographic characteristics and primary endpoint, incidence of wound composite outcome was observed. Moreover, no significant difference in suture extrusion and loosening, suture removal and evaluation of microbial deposits on sutures, operative time, intraoperative suture handling, pain, return to normal day-to-day activities, modified Hollander cosmesis, and subject satisfaction score were registered between the groups. Conclusions: This study establishes the clinical equivalence of Monoglyde® and Monocryl® poliglecaprone-25 sutures and both sutures can be used for subcuticular skin closure following cesarean delivery with minimal risk for wound complications.