Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flam… (NCT07468890) | Clinical Trial Compass
SuspendedNot Applicable
Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal
Stopped: Study paused for ongoing amendment and change of CI.
United Kingdom60 participantsStarted 2024-02-24
Plain-language summary
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
REEDA Score
Timeframe: Enrolement to 3 weeks postpartum
2
Participant self-reported symptom scores
Timeframe: 0, 1 and 3 weeks postpartum
Trial details
NCT IDNCT07468890
SponsorGloucestershire Hospitals NHS Foundation Trust