NCT05330767终止不适用
DermaClose Continuous External Tissue Expander for the Management of Four-Compartment Fasciotomy and Full-Thickness Wounds.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds
研究概览
简要总结
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is at least 18 years of age at the time of consent.
- •Patient with a full thickness acute wound(s) of the skin:
- •On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
- •Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.
- •Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).
排除标准
- •Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
- •Patient with wound(s) that exhibit any of the following:
- •Ischemic tissue,
- •Infected tissue,
- •Acute burned tissue,
- •Fragile tissue at the edges of the wound(s).
- •Patient, who in surgeon's opinion, does not fit the criteria for this study.
结局指标
主要结局
Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds
时间窗: Up to 14 Days (or longer if deemed necessary by surgeon)
Wounds may result from four-compartment leg fasciotomies.
次要结局
- Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy(Up to 60 Days)
- Median number of days until wound closure(Up to 14 Days (or longer if deemed necessary by surgeon))
- Number of days until hospital discharge(Up tp 60 Days)
- Mean percentage of wound size reduction(Up to 14 Days (or longer if deemed necessary by surgeon))
- Proportion of wounds requiring subsequent surgical procedure(s) for wound closure(Up to 60 Days)
研究者
研究点 (1)
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