Study paused for ongoing amendment and change of CI.

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

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.

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

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.