Randomized, Prospective, Pilot Study Evaluating a Temporary Skin Substitute (AWBAT-D) Versus the Standard of Care in the Postoperative Treatment of Split-thickness Skin Graft Donor Sites
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time for donor site to heal with AWBAT-D
研究概览
简要总结
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.
详细描述
The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve randomizing subjects to treatment with the AWBAT-D dressing or Tegaderm and monitoring outcomes. The AWBAT-D device has collagen and we hypothesize that the wounds treated with it will heal faster and with a decreased pain level. The purpose of this study is to evaluate if there are differences in outcomes between AWBAT-D and Tegaderm in healing split thickness skin graft donor sites.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is 18 years of age or older
- •Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
- •Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
排除标准
- •Subjects < 18 years of age
- •Subjects with an allergy to porcine products.
- •Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm
- •Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
- •Subjects undergoing repeat skin graft harvesting at the same donor site.
- •Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- •Subjects participating in any other trials involving the split-thickness skin graft donor site.
研究组 & 干预措施
AWBAT-D
Application of AWBAT-D on donor site.
干预措施: AWBAT-D (Device)
Control
Treatment with Tegaderm
干预措施: AWBAT-D (Device)
结局指标
主要结局
Time for donor site to heal with AWBAT-D
时间窗: 6 weeks
As compared to current standard of care, Tegaderm.
次要结局
- Pain at donor site(6 weeks)
研究者
Christopher Attinger, M.D.
Director of Center for Wound Healing
Georgetown University