Perineal Tear and EpisiotomyFLAMINGONCT07468890
Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal
A study testing Flaminal anti-microbial gel in people with Perineal Tear and Episiotomy and Perineal Laceration, Tear, or Rupture During Delivery, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perineal Tear and Episiotomy, Perineal Laceration, Tear, or Rupture During Delivery
- What is being tested?
- Flaminal anti-microbial gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Gloucestershire Royal Hospital
Gloucester, Gloucestershire, GL1 3NN
About this study
Official title: Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal: A Pilot Study
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.
Read the detailed description
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.
- Being tested
- Flaminal anti-microbial gel
- Medical subject headings
- Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaminal anti-microbial gelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Flaminal treatment | Active comparator | Flaminal treatment \& standard patient information perineal wound care leaflet Receives: Device: Flaminal anti-microbial gel |
| Advice only | No intervention | Standard perineal wound care leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 0, 1 and 3 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start24 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study paused for ongoing amendment and change of CI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal Tear and EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468890
- Sponsor's protocol ID
- 24/122/GHT
- Other IDs
- 23/SC/0202, 325686
- Acronym
- FLAMINGO
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal: A Pilot Study
- ClinicalTrials.gov ID
- NCT07468890
- Acronym / sponsor ID
- FLAMINGO / 24/122/GHT
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study paused for ongoing amendment and change of CI.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flaminal treatment | Active comparator | Device: Flaminal anti-microbial gelFlaminal treatment \& standard patient information perineal wound care leaflet |
| Advice only | No intervention | –Standard perineal wound care leaflet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flaminal anti-microbial gelFlaminal 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. | Device | Flaminal treatment |
Primary outcome
REEDA Score
Time frame: Enrolement to 3 weeks postpartum
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.
Participant self-reported symptom scores
Time frame: 0, 1 and 3 weeks postpartum
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: 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.
Related trials for Perineal Tear and Episiotomy
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up
Pregnancy, Childbirth
Recruiting
Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia
Dyspareunia
Active, not recruiting
Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
Episiotomy Extended by Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaminal anti-microbial gel in people with Perineal Tear and Episiotomy and Perineal Laceration, Tear, or Rupture During Delivery, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REEDA Score (time frame: Enrolement to 3 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.