Treatment of Wounds Using Oasis® Extracellular Matrix in the Community Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Wound healing
研究概览
简要总结
The purpose of this clinical study is to gather post-market clinical evidence on the use of Oasis ECM as a treatment for donor site wounds in the community setting in the United Kingdom.
详细描述
This prospective randomized controlled clinical study is being performed to evaluate the safety and performance of OASIS Extracellular Matrix when used as a treatment for donor site wounds as compared to standard wound care. This study will consent and treat up to 40 patients with 20 patients assigned to the OASIS treatment group and 20 patients assigned to the standard wound care treatment group.
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
- •1. Non-healing ulcer (any etiology) present for at least 1 month and treated in the ambulatory clinic or home healthcare setting
排除标准
- •Age < 18 years
- •Unable or unwilling to provide informed consent
- •Unable or unwilling to comply with the study follow-up schedule, and procedures
- •Simultaneously participating in another investigational drug or device study
- •Target wound area is < 2 cm2 or > 140 cm2 after baseline debridement
- •Target wound has reduced in area by > 40% with 4 weeks of documented standard of care therapy
- •Known allergy to pig or porcine products
- •Systemic infection
- •Infection of the target wound as determined by the collection of pus
- •Osteomyelitis
- •ABI/TBI < 0.6 obtained within 3 months prior to the screening visit
- •Other exclusions may apply
研究组 & 干预措施
20 patients assigned to the OASIS treatment group
After skin graft is taken, OASIS will be applied to the donor site.
干预措施: Oasis Extracellular Matrix (Device)
20 patients assigned to the standard wound care
After skin graft is taken, donor site will be treated with standard wound care.
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
Wound healing
时间窗: 12 weeks
To demonstrate the percentage of patients with wounds progressing to at least 50% healing
次要结局
- Wound closure- Percentage(up to 12 weeks)
- Wound closure- Mean Percentage(up to 12 weeks)
- Wound closure- Mean number of weeks(up to 12 weeks)
- Patient reported Quality of Life measurement(up to 12 weeks)
- Adverse Events(up to 12 weeks)