Clinical equivalence of Trusynth fast® and Vicryl rapide® polyglactin 910 fast absorbing sutures on maternal morbidity experienced by women following episiotomy repair: a single-blind, randomized study

Abstract

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

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

“…The volume of local anesthesia, intraoperative suture handling, number of sutures, and total time spent on episiotomy repair were measured. Early and late wound complications, as defined by the previous study [ 9 ], such as swelling, wound infection, wound dehiscence, hematoma, puerperal fever, urinary incontinence, and frequency of wound re-suturing were also noted. In addition, the number and dosage of analgesics, time taken for complete healing, presence of residual suture, return to sexual activity and dyspareunia, and adverse events were recorded.…”

“…Short- and long-term perineal pain and post-delivery complications may be affected by the material of the suture used for episiotomy repair [ 3 , 12 ]. Many studies are available regarding the clinical effectiveness of polyglactin 910 and fast-absorbing polyglactin 910 for episiotomy repair [ 7 - 9 , 13 - 15 ], but none compared the two brands of polyglycolic acid sutures. The present study has compared Truglyde Fast ® and Safil Quick ® polyglycolic acid fast-absorbing sutures in relation to maternal morbidity after episiotomy repair.…”

“…A previous single-blind, randomized study (Clinical Trials Registry - India (CTRI) registration number: CTRI/2020/12/029925) by the same sponsor (Healthium Medtech Limited) has compared the clinical equivalence of Trusynth Fast ® and Vicryl Rapide ® polyglactin 910 fast-absorbing sutures on maternal morbidity in women undergoing episiotomy repair [ 9 ]. The study is similar to the present study, except for the sutures used for episiotomy repair.…”

“…The study is similar to the present study, except for the sutures used for episiotomy repair. A likely methodology for conducting research as discussed in the previous study [ 9 ] is also followed in the present study.…”

“…Polyglycolic acid sutures are synthetic and absorbed by hydrolysis (~42 days), causing less tissue reaction [ 6 ]. Although studies are comparing the clinical effectiveness of polyglactin 910 and fast-absorbing polyglactin 910 with catgut [ 7 , 8 ] and fast-absorbing polyglactin 910 sutures (Trusynth Fast ® versus Vicryl Rapide ® ) [ 9 ] in case of episiotomy repair, no randomized controlled trial was conducted comparing two brands of polyglycolic acid sutures for episiotomy repair till date. Therefore, this study evaluated and compared Truglyde Fast ® (Healthium Medtech Limited, Bengaluru, India) and Safil Quick ® (B. Braun Medical Private Limited, Mumbai, India) polyglycolic acid sutures for episiotomy repair on maternal morbidity.…”