A Randomized, Single-Blind Study Comparing the Clinical Equivalence of Truglyde Fast® and Safil Quick® Polyglycolic Acid Fast-Absorbing Sutures for Episiotomy Repair Following Vaginal Delivery.

INTRODUCTION

Episiotomy, the deliberate surgical incision on the vaginal orifice during vaginal delivery, requires prompt repairing of the incised tissue. It may be associated with bleeding, infection, dehiscence, dyspareunia, short-term pain, and prolonged hospital stay. The outcome of surgery depends on the suture material and technique to repair the episiotomy.

OBJECTIVE

We aim to subjectively assess perineal pain and maternal morbidity following episiotomy repair with Truglyde Fast® (Healthium Medtech Limited, Bengaluru, India) and Safil Quick® (B. Braun Medical Private Limited, Mumbai, India) polyglycolic acid fast-absorbing suture.

MATERIALS AND

METHODS

This multicentric, prospective, randomized (1:1), two-arm, parallel-group, single-blind study was started in August 2020 and completed in March 2021. Ninety-nine primiparous or multiparous eligible women requiring episiotomy were recruited to Truglyde Fast® (n=51) and Safil Quick® (n=48) groups. The primary outcome measure was post-episiotomy perineal pain to be assessed using a visual analog scale (VAS). Secondary endpoints included evaluation of local anesthesia (quantity), intraoperative suture handling, number of sutures utilized, time spent for episiotomy repair and complete healing, analgesic number and dosage, early and late wound complications, presence of residual suture and frequency of re-suturing, resumption of sexual activity and dyspareunia, and adverse events. The threshold to discriminate significant from non-significant outcomes was p<0.05.

RESULTS

At all visits, a non-significant change in perineal pain was noted between Truglyde Fast® and Safil Quick® groups. A significant difference (p<0.05) in the number of sutures used and intraoperative handling characteristics was observed between thegroups. Results of other secondary endpoints showed non-significant differences.

CONCLUSION

Truglyde Fast® and Safil Quick® polyglycolic acid fast-absorbing sutures are clinically equivalent. Both sutures are safe and effective for episiotomy repair following vaginal delivery with minimal perineal pain and risk of maternal morbidity.