The Technique of Skin Stretching for Acute Burn Treatment and Scar Reconstruction: Clinical Applications and Working Mechanisms.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the surface area of the scar after 12 months
研究概览
简要总结
Objective:
A randomized controlled trial is performed to evaluate the clinical effectiveness of the skin stretching technique for two categories:
- acute burn wounds: wound closure by means of skin stretching should lead to a significant reduction of scar surface area in comparison to the standard technique, the split skin grafting;
- scar reconstructions: wound closure by means of skin stretching during one operative procedure should lead to a comparable scar surface in comparison to the multiple procedures techniques such as serial excision.
Study design:
Skin stretching will be compared to split skin grafting and should result in burn wound closure with significantly smaller scars. Also, a comparison will be made between the technique of serial excision versus skin stretching for scar reconstructions.
Scar evaluation three and twelve months after surgery will include the following parameters:
- surface area;
- Patient and Observer Scar Assessment Scale (POSAS);
- elasticity;
- vascularization and pigmentation;
- thickness;
- dermal architecture.
After 12 months adults will undergo a biopsy of the scar under local anesthesia. The experimental group, treated with the skin stretcher will undergo one extra biopsy of the formerly stretched skin.
Intervention:
At the start of the operation will be determined by randomization if skin stretching or split skin grafting (acute burn wounds) or serial excision (scar reconstruction category) will be performed.
详细描述
Eligibility criteria:
Inclusion:
-
Acute Burn wounds or scar reconstructions that require surgical treatment; 2. Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure.
-
Age >= 18 years
Exclusion:
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
- All
- 接受健康志愿者
- 是
入选标准
- •Acute Burn wounds or scar reconstructions that require surgical treatment;
- •Sufficient healthy skin at (at least) one edge of the wound/scar must be available for the stretching procedure;
- •Age >= 18 years.
排除标准
- •Language barrier;
- •Known history of keloid formation;
- •Systemic diseases: Diabetes Mellitus, immunodeficiency, arterial insufficiency;
- •Local or systemic application of corticosteroids;
- •Psychiatric diseases leading to study bias (e.g. automutilation);
- •Skin diseases that lead to collagen and/or elastin abnormalities such as Ehlers Danlos;
- •Radiated skin;
- •Wound located at extremities, exceeding >33% of circumference (acute burn category).
结局指标
主要结局
the surface area of the scar after 12 months
时间窗: 3 and 12 months after surgery
次要结局
- scar evaluation protocol: - patient and observer scar assessment scale (POSAS); - scar elasticity (Cutometer); - scar vascularization & pigmentation (DermaSpectrometer); - scar thickness(3 and 12 months after surgery)