Evaluation of Emergency Suturing With Absorbable Versus Non-absorbable Suture Material in a Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Short-term infection risk
研究概览
简要总结
The investigators recruit patients admitted to the Pediatric Emergency Department of the Geneva's University Hospital with open wounds needing suture. The patients are treated with absorbable versus non-absorbable suture material according to randomization.
Outcomes are:
- infection rate at the first follow-up (between 4 and 14 days, depending on the sutured site and defined by protocol)
- scar appearance at a 6-months follow-up.
详细描述
The investigators recruit patients admitted to the Pediatric Emergency Department of the Geneva's University Hospital with open wounds needing suture. The patients are treated with absorbable versus non-absorbable suture material according to randomization.
After obtaining the patient's/parent's consent and randomization, the suture material will be provided.
Selection of the size of the thread and the date of the first follow-up are determined as follows:
- Face: Thread size 5-0 to 7-0, first follow-up 4-7 days
- Torso/back: Thread size 4-0 or 5-0, first follow-up 10-14 days
- Arms: Thread size 4-0 or 5-0, first follow-up 7- 10 days
- Hand: Thread size 5-0 or 6-0, first follow-up 7-10 days
- Legs: Thread size 4-0 or 5-0, first follow-up 7-14 days
The patients are examined by in the outpatient wound clinic by specialised nurses under medical supervision at the first follow-up, and at six months by one of the investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 1 Day 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient younger than 16 years of age with a wound requiring suture
排除标准
- •Deep wounds with lesions of subcutaneous structures (tendons, nerves, etc.)
- •Wounds with tissue loss
- •Diabetic patients or patients treated with drugs potentially compromising cicatrization (e.g. steroids, immunosuppressors, etc.)
- •Wounds caused by animal or human bites
- •Sutures not performed in the emergency room
- •Heavily soiled wounds
结局指标
主要结局
Short-term infection risk
时间窗: 4 to 21 days
Scars classified as "no evidence of infection", "signs of inflammation" and "signs of active infection"
次要结局
- Scar appearance(6 months)
研究者
Giorgio La Scala
PD, MD; Attending Surgeon
University Hospital, Geneva