Improving the Management and Prevention of Perineal Wound Dehiscence From Episiotomies Using Flaminal: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- REEDA Score
研究概览
简要总结
The objectives of this study are to assess the effectiveness of Flaminal Forte in the treatment and prevention of perineal wound breakdown.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Flaminal treatment
Flaminal treatment & standard patient information perineal wound care leaflet
干预措施: Flaminal anti-microbial gel (Device)
Advice only
Standard perineal wound care leaflet
结局指标
主要结局
REEDA Score
时间窗: Enrolement to 3 weeks postpartum
Evaluating perineal healing at 3 weeks postpartum using the REEDA score (redness, edema, ecchymosis, discharge and approximation). Comparison between treatment arms.
Participant self-reported symptom scores
时间窗: 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).
次要结局
未报告次要终点