Restore Calcium Alginate Dressing, Silver vs Aquacel Ag in the Treatment of Critically Colonized Venous Leg Ulcers
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 10
- 主要终点
- The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure.
研究概览
简要总结
Calcium alginate dressings with silver have been found to be safe and effective for use for leg ulcers. The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure. The secondary objective is to obtain photographic documentation of the leg ulcers during the course of the study.
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
- •Is 18 years or older; male or female.
- •Previous diagnosis of venous insufficiency proven by a positive venous duplex with reflux.
- •Has a venous ulcer with a wound area between 5 cm2 - 40 cm
- •Has an ankle brachial index (ABI) >0.
- •Has a venous ulcer with duration less than 24 months.
- •Has a venous ulcer which is critically colonized (not infected) based on the Lazareth Study Model. Ulcers are considered to be critically colonized if at least three of the five following signs are present:
- •Severe spontaneous pain between two dressing changes,Perilesional erythema,Local edema,Malodour,Heavy Exudation
- •Is currently using Profore as their standard of care.
- •Has not received antibiotics for 6 weeks prior to enrollment.
排除标准
- •Has an allergy to one of the components of the dressings (calcium alginate, hydrocolloid [carboxymethylceullose], silver).
- •Is currently on antibiotics.
- •Has a negative venous duplex.
- •Is unable to tolerate 4 layer compression.
- •Is unable to continue contact with the investigator for a period of at least two weeks.
- •Is unwilling or unable to comply with the study protocol.
结局指标
主要结局
The primary objective is to compare Restore Calcium Alginate Dressing, Silver to AqualCel Ag Dressing on the following parameters: No further progression toward infection (bioburden), ease of application and removal, and percent progression to closure.
时间窗: Observations will be collected over 6 weeks for a total of 7 visits
次要结局
- The secondary objective is to obtain photographic documentation of the venous leg ulcers during the course of the study.(Observations will be collected over 6 weeks in a total of 7 visits.)