NCT02363543撤回4 期
Comparison of Hyalomatrix and Integra Wound Matrix on Burn Wounds
Medline Industries0 个研究点开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Wound Infection Rate
研究概览
简要总结
The purpose of this randomized, comparative study is to determine whether Hyalomatrix is as effective as IntegraTM Meshed Bilayer Wound Matrix when used in subjects who receive concurrent treatments with both products on their first and/or second degree burns located on both hands.
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
- •Written consent must be obtained
- •First and/or second degree burns on both hands
- •Subject must be enrolled within 48 hours of the injury occurrence.
排除标准
- •Subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation.
- •Subject has a prognosis that indicates unlikely survival past the study period.
- •Subject's diagnosis indicates third degree burns.
- •Subject suffers from burns sustained as a result of an electrical/chemical injury or by frostbite.
- •Subject suffers from any inhalation-related burn trauma.
- •Subject suffers from ongoing bone fractures.
- •Subject has a known sensitivity to materials containing silicone, hyaluronan, bovine collagen, or chondroitin and/or derivatives of these products.
- •Subject has received any treatment prior to study enrollment that may, in the opinion of the Investigator, affect the outcome of the study.
- •Subject suffers from a medical condition that may impede wound healing, above any beyond that which would typically be expected.
研究组 & 干预措施
Hyalomatrix
Active Comparator
Sterile, single use, flexible, and conformable wound dressing comprised of a derivative of hyaluronic acid which acts as a three dimensional regenerative matrix.
干预措施: Hyalomatrix (Device)
Integra
Active Comparator
Sterile, single use, wound care dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan
干预措施: Integra (Device)
结局指标
主要结局
Wound Infection Rate
时间窗: Up to 21 days
Number of days required for wound healing
时间窗: Up to 21 days
次要结局
- Range of Motion Scores(Up to 21 days)
- Physician Scores on Products Ease of Use(Up to 21 days)
研究者
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