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

NCT07468890 | Suspended

• 3 other identifiers: 24/122/GHT23/SC/0202325686
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perineal Tear and Episiotomy; Perineal Laceration, Tear, or Rupture During Delivery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Flaminal treatment

ACTIVE COMPARATOR

Flaminal treatment \& standard patient information perineal wound care leaflet

Device: Flaminal anti-microbial gel

Advice only

NO INTERVENTION

Standard perineal wound care leaflet

Interventions

Flaminal anti-microbial gel DEVICE

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.

Flaminal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Women attend hospital with an episiotomy-related wound breakdown
• Over 18 years of age, under 45 years of age
• Able to provide informed consent
• Patients who require surgical debridement as part of their treatment
• rd/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

Sponsors & Collaborators

• Gloucestershire Hospitals NHS Foundation Trust: lead

Study Sites (1)

Gloucestershire Royal Hospital

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 13, 2026
• Study Start: February 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)