Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
研究概览
简要总结
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject is 18 to 85 years of age inclusive
- •subject has a foot ulcer
- •subject has a leg ulcer
- •subject has an open wound of at 1.0 cm (2)
- •subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg
- •subject or legally authorized rep is able to understand and willing to give written informed consent
排除标准
- •subject has an allergy to Chlorhexidine Gluconate (CHG)
- •subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
- •subject has current malignant disease or history of malignant disease in past 5 years
- •subject has inability to comply with the study protocol and procedures
- •subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
研究组 & 干预措施
Arm 1
干预措施: COPA AMD (note: name is not an acronym) (Device)
Arm 2
干预措施: COPA (note: name is not an acronym) (Device)
结局指标
主要结局
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
时间窗: 5 weeks
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.
时间窗: Weeks 0 and 4
At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.
次要结局
- Pain(5 weeks)