A study comparing two brands of similar suture materials (Trusynth FastÂ® and Vicryl RapideÂ®) for suturing after vaginal delivery

Not Applicable

Completed

Brief Summary: Episiotomy is a surgical incision of the perineum (the area between the vaginal opening and back passage) to enlarge the vaginal opening during labor or delivery. This procedure is done with scissors or scalpel and requires repair by suturing. Polyglactin 910 fast-absorbing sutures are commonly used for episiotomy repair as it is associated with less perineal pain, analgesic use, infection and re-suturing. In this study, we plan to assess differences in maternal morbidity between two commonly used brands of polyglactin 910 fast-absorbing sutures, Trusynth FastÂ® and Vicryl rapideÂ®.

Recruitment & Eligibility

Inclusion Criteria

Women aged 18-40 years, with a singleton pregnancy 2.
Primiparous or multiparous women who will require episiotomy during the course of vaginal delivery 3.
Women with gestational age of >34 weeks 4.
Women with good systemic/ mental health as per opinion of investigator 5.
Women who have given informed consent.

Exclusion Criteria

Women with intrapartum fever and history of bleeding/coagulation disorders 2.
Women having perineal tears, cervical tears, vaginal tears, extension of the episiotomies 3.
Women who had a previous perineal surgery other than the primary repair after child birth 4.
Women with known HIV or the hepatitis B infection 5.
Women who has delivered a dead fetus 6.
Women having any known allergy to the suture materials 7.
Women already participating in another trial 8.
Women unlikely to comply with study procedure or complete the scheduled follow up visit, in the opinion of investigator 9.
Other indication-based exclusion, in the opinion of investigator.

Primary Outcome Measures

Name	Time	Method
1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth FastÂ® and Vicryl RapideÂ®	Day 2, Day 11, Week 6 and Week 12

Secondary Outcome Measures

Name	Time	Method
1. To compare the use of analgesics in both the groups	2. To evaluate the wound healing in both the groups

Locations (2): Father Muller Medical College
🇮🇳
Kannada, KARNATAKA, India
Government Victoria Hospital
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Father Muller Medical College
🇮🇳Kannada, KARNATAKA, India
Dr Chethana Bolanthakodi
Principal investigator
9901892381
bc3bhat@yahoo.co.in