RESUMO
Background: Episiotomy procedure enlarges the vaginal outlet to facilitate childbirth. Polyglactin 910 fast-absorbing sutures are widely used for the repair of episiotomy because of their rapid absorption and less inflammatory response. This study was designed for subjective assessment of perineal pain post-episiotomy repair, with Trusynth Fast ® and Vicryl Rapide ® polyglactin 910 fast-absorbing sutures. Method: This was a single-blind, randomized, prospective study conducted between January 7, 2021 and July 14, 2021 across two centers in India. Primiparous or multiparous women (18-40 years), who required episiotomy during vaginal delivery were included, and either Trusynth Fast ® (n=47) or Vicryl Rapide ® (n=49) suture was used for their episiotomy repair. The primary endpoint, perineal pain was assessed with visual analogue scale at all follow-up visits. The secondary endpoints, quantity of local anesthesia, number of sutures used, time to repair episiotomy, intraoperative suture handling, analgesics used, early and late wound complications, wound re-suturing, time to complete healing, presence of residual sutures, return to sexual activity, dyspareunia, and adverse events were also recorded. Results: The study showed no significant difference in perineal pain between the two groups at any visit. A statistically significant difference (p<0.05) in total score of episiotomy healing scale on day 2 (0.13±0.34 versus 0.35±0.56) and swelling on day 2 (8.51 versusversus 28.57%) was noted between Trusynth Fast ® and Vicryl Rapide ® group. Non-significant difference was observed between the groups regarding anesthesia, number of sutures, time to repair episiotomy, intraoperative suture handling, analgesics, puerperal fever, wound infection, dehiscence, hematoma, urinary incontinence, re-suturing, time to complete healing, return to sexual activity and dyspareunia. Conclusion: Trusynth Fast ® suture is clinically equivalent to Vicryl Rapide ® suture and can be used for episiotomy repair with minimal risk of perineal pain and wound complications. Clinical Trials Registry of India Registration: CTRI/2020/12/029925; Registered on December 18, 2020.
