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

Phase 4

Completed

• Conditions: Health Condition 1: O80- Encounter for full-term uncomplicated delivery

• Registration Number: CTRI/2020/12/029925
• Lead Sponsor: Healthium Medtech Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-14
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. 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

1. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Subjective assessment of perineal pain post episiotomy repair, with Trusynth Fast�® and Vicryl Rapide�®Timepoint: 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 <br/ ><br>2. To evaluate the wound healing in both the groups <br/ ><br>3. To evaluate resumption of sexual activity and dyspareunia in both the groups <br/ ><br>4. To assess overall intraoperative handling between two sutures <br/ ><br>5. To evaluate no. of sutures utilized and residual suture removal in both the groups <br/ ><br>6. To evaluate maternal morbidities post episiotomyTimepoint: Day 2, Day 11, Week 6 and Week 12