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

Gloucestershire Hospitals NHS Foundation Trust

Status

Suspended

Conditions

Perineal Tear and Episiotomy

Perineal Laceration, Tear, or Rupture During Delivery

Treatments

Device: Flaminal anti-microbial gel

Study type

Interventional

Funder types

Other

Identifiers

NCT07468890

325686 (Other Identifier)

24/122/GHT

23/SC/0202 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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