NCT07468890

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

Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal: A Pilot Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Gloucestershire Hospitals NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-24
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-03-13
• Last updated: 2026-03-19

Locations

1 site across 1 country: United Kingdom