A Phase IIIb, Randomized Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- To evaluate the proportion of subjects healed.
研究概览
简要总结
This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state.
The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative must provide written informed consent.
- •Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent.
- •The subject is scheduled to undergo a split-thickness skin graft (autograft)
- •Harvesting of the donor site must be limited to the location and size of the anterior thigh
- •The selected anterior thigh must be a first - time harvesting.
排除标准
- •Subjects with known skin sensitivity to any of the dressing components.
- •Subjects who require a full thickness graft.
- •The subject with a poor prognosis, which would make it unlikely that he/she would survive the 21 day study period.
- •Subjects who have been previously randomized into the study, or who are presently participating in another clinical trial.
结局指标
主要结局
To evaluate the proportion of subjects healed.
时间窗: 14 days
次要结局
- Time to healing.(14 days)
- Degree of pain at dressing change.(14 days)
- Degree of pain/discomfort while wearing the dressing at rest and during mobility.(14 days)
- Investigator's rating of dressing performance (per subject and overall).(14 days)
- Resources utilization.(14 days)
- Readiness for re-harvesting.(day 14)
- Safety.(14 days +30)