The New Skin Stretching Device for Treatment of Limb Tension Wounds: A Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the change of surface area of the scar
研究概览
简要总结
A randomized controlled trial is performed to evaluate the effectiveness and safety of the Skin Stretching Device (SSD) on limb tension incision closure by comparing whether the differences in wounds area, wounds closure time and scar assessment between the SSD and the skin grafting are statistically significant.
详细描述
Design:
This study is a multicenter and randomized control study with the participation of 15 major national or regional central hospitals. And the whole sample size is set to be 100 patients.
Patients who have been screened by inclusion and exclusion criteria will be randomly (non-transparent envelope) assigned to Skin Stretching Group (SS Group) or Skin Grafting Group (SG Group). Patients of both group will undergo surgical debridement for the same principle, while the Skin Stretching Device is used for the patients of SS Group for incision closure and the Skin Grafting is used for the patients of SG group for incision closure.
Outcome evaluation:
Wound and scar evaluation during surgery, three and six months after surgery will include the following parameters:
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 (Participant, Investigator)
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 years old
- •Tension incision that cannot be directly closed due to limb trauma or surgical debridement
- •Incision that cannot be directly closed after the incision decompression for fascia compartment syndrome and ischemia and reperfusion injury
- •Both sides of the incision skin suitable for skin stretching
排除标准
- •Age <18 years old
- •Skin disease
- •Keloid history
- •Local or systemic use of hormones
- •Systemic diseases: for example, diabetes, immunodeficiency disease, vascular disease and etc.
- •Other poor general state to result in inability for trial;
- •Mental illness.
结局指标
主要结局
the change of surface area of the scar
时间窗: change from surgery at 6 months
it is performed by tracing the area of the scar directly onto non-stretchable transparent sterile sheets. then digitized and analyzed by software.
次要结局
- Operation time(during surgery)
- Vancouver scar scale (VSS)(3 and 6 months after surgery)
- scar vascularization index(3 and 6 months after surgery)
- Wound site and wound healing time(from surgery to 6 months)
- scar pigmentation index(3 and 6 months after surgery)
- dermal matrix arrangement under electron microscopy(surgery and 6 months after surgery)
- collagen fibers arrangement under electron microscopy(surgery and 6 months after surgery)