NCT04050124已完成不适用
Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Pain Score on Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled to undergo STSG for any reason
- •Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form.
排除标准
- •Active infection or history of radiation to the donor site
- •Patient has a known sensitivity to Promogran Prisma™ or silver
- •Elevated INR >3.0
- •Insensate at the donor site
- •Chronic narcotic use (>6 months of daily use)
结局指标
主要结局
Pain Score on Visual Analogue Scale (VAS)
时间窗: Postoperative Day 1
Pain score is measured using a VAS ranging from 0-10, where 0 = no pain and 10 = unbearable pain. Participants select the number that best reflects their current status. The total score is the numerical response; lower scores indicate lower pain.
次要结局
未报告次要终点
研究者
研究点 (1)
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