NCT00343824已完成不适用
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
研究概览
简要总结
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
- •Wounds treated with a hydrocolloid paste prior to LDI
- •Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
- •Informed consent
- •Partial thickness burns with TBSE < 40%
排除标准
- •Mean flux values < 200 or > 1000
- •TBSA > 40%
- •Impossibility to debride necrotic skin prior to LDI measurement
- •Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
- •Not following the complete treatment schedule or missing some evaluations during the follow-up period
- •Patient has any condition that seriously compromises the patient's ability to complete the study
- •Patient has participated in another study using an investigational drug within the previous 30 days
- •Patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study
- •The plastic surgeon decides that surgery is necessary due to unusual circumstances
- •Patient wish to decline from the study
- •No informed consent
- •Full thickness burns
结局指标
主要结局
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
时间窗: Over a period of 21 days
次要结局
- Comparison of blood silver levels(Every week until woundhealing. In folluw-up: at 3, 6 and 12 months)
- Scar quality assessment(At 1, 3, 6 and 12 months after wound closure)
- Percentage of genetically-acquired resistance to silver(Once after wound closure.)
- Health related quality of life(At 1, 3, 6 and 12 months after wound closure)
- Cost-effectiveness(Once after wound closure.)
- Healing time comparison(Every 3 days until healing)
研究者
研究点 (2)
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