NCT04899466招募中不适用
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of complete wound closure
研究概览
简要总结
This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two).
An historic matched-control group of 20 patients will be compared retrospectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Women that had a laparotomy no more than 3 weeks before accrual.
- •Surgical wound dehiscence that requires a secondary closure.
- •Time from wound dehiscence >24 hours and <6 days.
- •The open wound includes epidermis, dermis and sub cutaneous fat.
- •The patient can sign an informed consent form.
排除标准
- •Patients with necrotizing fasciitis
- •Patients with fascial dehiscence
- •Cannot withdraw blood in the required amount (up to 18 mL per week).
- •Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded.
- •Pregnancy
- •Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).
结局指标
主要结局
Incidence of complete wound closure
时间窗: 4 weeks
Skin re-epithelialization without drainage or dressing requirements
次要结局
- Mean time of complete wound closure(4 weeks)
- Comparison of time to complete closure between study cases and historic control(4 weeks)
- Wound Percent Area Reduction (PAR)(2, 4 and 6 weeks)
- Durability of wound closure 2 weeks after complete healing(Up to 6 weeks)
研究者
研究点 (1)
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