NCT04829331终止不适用
Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tendon Exposure
研究概览
简要总结
Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
- •Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.
排除标准
- •Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
- •Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
- •Morbid obesity (BMI >40).
- •Inability to maintain wrist immobilization for full planned period.
- •Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
- •Other conditions felt to significantly impair wound healing per surgeon discretion.
结局指标
主要结局
Tendon Exposure
时间窗: 4 weeks post-operatively
Percentage of participants with tendon exposure
Surface Area of Split-thickness Skin Graft Incorporation
时间窗: 4 weeks post-operatively
Percentage of surface area of split-thickness skin graft incorporation
次要结局
未报告次要终点
研究者
研究点 (2)
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