A Randomized Controlled Trial of Enzymatic Debridement of Pressure Ulcers With Clostridial Collagenase Ointment (SANTYL®) or Hydrogel (SoloSite®)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Proportion of Ulcers With Complete Debridement
研究概览
简要总结
This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term care setting, the removal of dead skin (debridement) with SANTYL® resulted in more participants achieving complete debridement, more rapidly than when SoloSite® is used. The goal of the present study is to confirm the results of the earlier study, demonstrating superior debridement outcomes for pressure ulcers of patients in long-term care as compared to ulcers managed with SoloSite®.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of Ulcers With Complete Debridement
时间窗: 6 weeks
For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.
次要结局
- Time in Days to Complete Debridement(6 weeks)
- Percentage Reduction in Ulcer Area(6 weeks)
- Pressure Ulcer Scale for Healing (PUSH) Score(6 weeks)
- Wound Bed Sore (WBS) Score(6 weeks)
- Percentage Reduction in Non-viable Tissue(6 weeks)