Pilot Study Comparing Taliderm™ Dressing Versus Standard of Care for Open Incision and Drainage of Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits.
研究概览
简要总结
To evaluate wound healing with the use of Taliderm™ dressing and compare it to wet to dry dressing in the treatment of open wounds after incision and drainage.
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
- 否
入选标准
- •Inpatients with soft tissue abscess that will result in an open surgical wounds greater than or equal to 4 cms in any dimension
- •Wound will require serial dressing changes
- •Greater than or equal to 18 years of age
- •Ability to obtain informed consent
排除标准
- •Inability to obtain informed consent
- •Pregnancy
研究组 & 干预措施
III
standard wet to dry dressing with gauze
干预措施: standard wet to dry dressing with gauze (Other)
Group II
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing. Gauze dressing changes will continue per standard of care until the scheduled follow-up visits (first or second visit). At the scheduled follow-up visits, the subject will have a Taliderm™ dressing applied and left in place until the next scheduled dressing change (up to eight hours), then will continue standard of care wet to dry gauze dressing changes until next scheduled follow-up visit.
干预措施: Taliderm™ (Other)
group I
Taliderm™ dressing applied until the next scheduled dressing change (up to eight hours), then replaced by a gauze dressing
干预措施: Taliderm™ (Other)
结局指标
主要结局
The primary endpoint of this study will be rate of wound healing (judged as per cent complete wound closure) at the two (2) and three (3) week follow-up visits.
时间窗: two and three weeks
次要结局
- occurence of wound infection(two and three weeks)