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

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.

Study Overview

• Status: Suspended
• Conditions: Perineal Tear and Episiotomy; Perineal Laceration, Tear, or Rupture During Delivery
• Intervention / Treatment: Device: Flaminal anti-microbial gel

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Gloucestershire Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flaminal treatment; Flaminal treatment & standard patient information perineal wound care leaflet	Device: Flaminal anti-microbial gel; 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.
No Intervention: Advice only; Standard perineal wound care leaflet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	0, 1 and 3 weeks postpartum
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.	Enrolement to 3 weeks postpartum

Collaborators and Investigators

• Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 24/122/GHT; 23/SC/0202 (Other Identifier: South Central - Berkshire Research Ethics Committee); 325686 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No