Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone
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)
研究组 & 干预措施
Promogran Prisma
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
干预措施: Promogran Prisma (Device)
Promogran Prisma
Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site.
干预措施: Standard of care (SOC) dressings (Device)
Standard of care (SOC) dressings
干预措施: Standard of care (SOC) dressings (Device)
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