Phenytoin in the Healing of Clean Surgical Wounds
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage rate of re-epithelialization
研究概览
简要总结
The purpose of this study is to investigate the potential healing properties of phenytoin.
The investigators will use the donor site of a split skin thickness graft (SSTG) to model a basic wound in a randomized controlled trial of topical phenytoin against current best clinical practice. The investigators aim to demonstrate a dose dependent effect. The investigators hypothesis, based on previous clinical experience at our center and on current available literature, that phenytoin will reduce wound healing time.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing split thickness skin graft during trial time period at Children's Surgical Centre
排除标准
- 未提供
研究组 & 干预措施
Control
Dressings of best current clinical practice, sugar solution.
干预措施: Sugar solution (Drug)
Phenytoin 1
Dressings using phenytoin solution 20mg/ml
干预措施: Phenytoin (Drug)
Phenytoin 2
Dressings using phenytoin solution 40mg/ml
干预措施: Phenytoin (Drug)
结局指标
主要结局
Percentage rate of re-epithelialization
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 20 days
Pictures taken of wound site every other day will be analysed using imaging software for size of wound. Percentage rate will be calculated from this.
Appearance of infection
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 20 days
Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale
次要结局
未报告次要终点