A study comparing two brands of similar suture materials (Truglyde FastÃ?Â® or Safil QuickÃ?Â®) for suturing after vaginal delivery

Single blind, randomized comparative study assessing clinical equivalence of two polyglycolic acid fast absorbing suture brands, Truglyde FastÃ?Â® and Safil QuickÃ?Â®, on maternal morbidity experienced by women following episiotomy repair

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/026040

Enrollment

100

Registered

2020-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Truglyde Fast SutureÃ?Â®: Truglyde Fast SutureÃ?Â® (Healthium) (Polyglycolic acid fast-absorbing suture

Suture will not be removed once it is applied) Control Intervention1: Safil Quick SutureÃ?Â®: Safil Quick SutureÃ?Â® (B. Braun) (Polyglycolic acid fast-absorbing suture

Suture will not be removed once it is applied)

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Subjective assessment of perineal pain post episiotomy repair, with Truglyde FastÃ?Â® and Safil QuickÃ?Â®Timepoint: Day 2, Day 11, Week 6 and Week 12	—

Secondary

Measure	Time frame
1. To compare the use of analgesics in both the groups 2. To evaluate the wound healing in both the groups 3. To evaluate resumption of sexual activity and dyspareunia in both the groups 4. To assess overall intraoperative handling between two sutures 5. To evaluate no. of sutures utilized and residual suture removal in both the groups 6. To evaluate maternal morbidities post episiotomyTimepoint: Day 2, Day 11, Week 6 and Week 12	—

Measure

Time frame

1. To compare the use of analgesics in both the groups 2. To evaluate the wound healing in both the groups 3. To evaluate resumption of sexual activity and dyspareunia in both the groups 4. To assess overall intraoperative handling between two sutures 5. To evaluate no. of sutures utilized and residual suture removal in both the groups 6. To evaluate maternal morbidities post episiotomyTimepoint: Day 2, Day 11, Week 6 and Week 12

—

Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Pvt.Ltd.

ashok.m@healthiummedtech.com9717887751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026