Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Scar cosmesis
研究概览
简要总结
The goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and over
- •Brachioplasty, Tighplasty, abdominoplasty, circumferential dermolipectomy in a massive weight loss patient
- •The subjects are in good health
- •The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
排除标准
- •Under 18 years of age
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
研究组 & 干预措施
Running sutures
Deep layers will be closed using running sutures
干预措施: Running sutures (Other)
Interrupted sutures
Deep layers will be closed using interrupted sutures
干预措施: Interrupted sutures (Other)
结局指标
主要结局
Scar cosmesis
时间窗: 6 months
The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
Scar cosmesis
时间窗: 15 days
The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
Scar cosmesis
时间窗: 1.5 months
The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
Scar cosmesis
时间窗: 3 months
The primary outcome measure of this study will be the evaluation of the scar quality. This outcome will be assessed by the Patient and Observer Scar Assessment Scale (POSAS). The patient and four blinded raters will assess the scars.
次要结局
- Adverse Events(6 months)
- Time spent suturing the wound(up to 24h)
- Number of suture thread needed(up to 24h)
- Measurement of Scar Width(6 months)
- Measurement of Scar Width(3 months)
- Adverse Events(15 days)
- Adverse Events(1.5 months)
- Adverse Events(3 months)
研究者
samer jabbour
M.D.
Fondation Hôpital Saint-Joseph