New gel could mend birth tears faster
NCT ID NCT07468890
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether Flaminal, an antimicrobial gel, can help heal and prevent wound breakdown after an episiotomy (a cut made during childbirth). Sixty women who had an episiotomy during a forceps or vacuum delivery will use the gel for up to three weeks. Researchers will measure healing using a standard scale and track symptoms like pain and swelling.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flaminal antimicrobial gel
- What this could lead to
- If it works, this could offer a simple, at-home gel to help heal perineal wounds after childbirth and prevent complications.
- What could go wrong
- This is a small pilot study with only 60 participants, and it is currently suspended. The gel may not prove more effective than standard care, and results may not apply to all women.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
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