NCT04880603终止2 期
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site
Nebraska Methodist Health System2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年4月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tendon exposure
研究概览
简要总结
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
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, 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-operation
Tendon exposure at four weeks post-operatively (Yes/No).
Percentage of surface area
时间窗: 4 weeks post operation
Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.
次要结局
未报告次要终点
研究者
研究点 (2)
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