Perineal Laceration, Tear, or Rupture During Delivery, Perineal Tear and Episiotomy
Conditions
Brief 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.
Interventions
DEVICEFlaminal 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.
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REEDA Score | Enrolement to 3 weeks postpartum | 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. |
| Participant self-reported symptom scores | 0, 1 and 3 weeks postpartum | 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). |
Countries
United Kingdom
Outcome results
None listed