An interventional study of Flaminal anti-microbial gel in Perineal Tear and Episiotomy and Perineal Laceration, Tear, or Rupture During Delivery, sponsored by Gloucestershire Hospitals NHS Foundation Trust. Suspended at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Gloucestershire Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.
The first part of the study is a prospective case-series review where Flaminal is used as a treatment of episiotomy-related wound breakdown in addition to other standard measures. Outcomes and patient experience after 3 weeks of treatment will be reviewed. This will involve assessment utilising the REEDA scale, specifically designed for the assessment of perineal trauma.
The second part of the study is a randomised controlled trial comparing women who used Flaminal, with the aim of preventing episiotomy-related wound breakdown, versus women who were treated with standard post-episiotomy advice and care. Assessment of the perineal wound healing will involve a self-reported symptom questionnaire at 0,1,3 weeks postpartum, as well as assessment of REEDA score when seen in clinic at approximately 3 weeks post-partum.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 60 is close to the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Gloucestershire Hospitals NHS Foundation Trust is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pilot Study Inclusion Criteria:
Pilot Study Exclusion Criteria:
Case Review Series Inclusion:
Case Review Series Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Flaminal treatment \& standard patient information perineal wound care leaflet
Device: Flaminal anti-microbial gel
Standard perineal wound care leaflet
Flaminal is a jelly-like anti-bacterial treatment which comes in a tube, this can be placed either directly onto the patients wound, or onto sanitary towel. Study staff will show participants how to use it. Participants will use the gel for up to 3 weeks.
REEDA Score
Evaluating perineal healing at 3 weeks postpartum using the REEDA scale (redness, edema, ecchymosis, discharge and approximation). Scores of 0 to 3 are recorded for each parameter (a lower score (0) indicating a better wound condition), giving a total score of 0-15 (a lower score (0) indicates better perineal healing and higher score shows poor healing). Comparison between treatment arms.
Time frame: Enrolement to 3 weeks postpartum
Participant self-reported symptom scores
Self-reported symptom questionnaire at 0,1,3 weeks postpartum to evaluate perineal pain, redness, swelling and wound gaping using 0 - 10 scale, from 0 (no symptom) to10 (severe symptom). Questionnaire also evaluates patient satisfaction using 0 - 10 scale, from 0 (not at all satisfied) to 10 (very satisfied).
Time frame: 0, 1 and 3 weeks postpartum
Plan to share: No — Non patient identifiable data regarding patients REEDA scores at each stage of treatment and they subjective experience of wound healing will be collected . The study will end when 60 patients have been recruited in the instrumental arm, and their follow up has been completed, as well as where approximately 10 perineal wound breakdown cases are recruited in the perineal breakdown arm, or 6 months have passed in total since data collection started, whichever is shorter. Proposed Publication The investigators propose to publish two articles relating to each arm of the project, electronically to the FlenHealth website -www.flenhealth.co.uk/professionals. The investigators also endeavour to publish our results in an indexed-linked journal as this study is novel and innovative, and could provide excellent scope for further work in the field of perineal wound care.
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2026, 34 months after the start.
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This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Gloucestershire Hospitals NHS Foundation Trust