SuspendedNot Applicable

Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal

Stopped: Study paused for ongoing amendment and change of CI.

United Kingdom60 participantsStarted 2024-02-24

Plain-language summary

The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Pilot Study Inclusion Criteria: * Women who underwent an episiotomy in the context of an operative vaginal birth (forceps/ suction cup aka ventouse) * Sutured using 2-0 absorbable suture material either Velosorb or Vicryl Rapide * Over 18 years of age * Able to provide informed consent Pilot Study Exclusion Criteria: * Episiotomy in the context of a normal vaginal birth * Extension into a 3rd/4th degree tear (more complicated tears involving anal sphincter muscles or the rectum) * Women under 18 years of age * Unable to provide informed consent * Patients who have had previous adverse reaction to Flaminal products Case Review Series Inclusion: * Women attend hospital with an episiotomy-related wound breakdown * Over 18 years of age, under 45 years of age * Able to provide informed consent Case Review Series Exclusion: * Patients who require surgical debridement as part of their treatment * 3rd/4th degree tears (more complicated tears involving anal sphincter muscles or the rectum * Under 18 years of age, over 45 years of age * Not able to provide informed consent * Patients who have had previous adverse reaction to Flaminal products

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

REEDA Score

Timeframe: Enrolement to 3 weeks postpartum

Participant self-reported symptom scores

Timeframe: 0, 1 and 3 weeks postpartum

Trial details

NCT IDNCT07468890

SponsorGloucestershire Hospitals NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Perineal Tear and Episiotomy trials