NCT00343824已完成不适用
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 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
研究组 & 干预措施
aquacel AG hydrofiber
Experimental
干预措施: aquacel AG hydrofiber versus acticoat burn dressing (Procedure)
Acticoat burn dressing
Experimental
干预措施: aquacel AG hydrofiber versus acticoat burn dressing (Procedure)
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
- Cost-effectiveness(Once after wound closure.)
- 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)
- Healing time comparison(Every 3 days until healing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNSBurn ScarBurn Second DegreeBurnsNCT04412759University Hospital, Linkoeping26
尚未招募
3 期
Bacterial nanocellulose wound dressings for the healing of second degree burn woundsSecond degree burn ulcer.Calcification and ossification of muscles associated with burnsM61.3IRCT20160117026069N6Karaj University of Medical Sciences24
已完成
不适用
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Superficial Dermal BurnBurnsNCT01598480Bio-medical Carbon Technology Co., Ltd.30
已完成
不适用
To Study the Healing Effect of Silver Impregnated Activated Carbon Fiber Wound Dressing on Deep Dermal BurnBurnsNCT01598493Bio-medical Carbon Technology Co., Ltd.30
终止
不适用
Alginate Dressings Versus Gauge Dressings After Pilonidal Cyst Resection: Examination of the Quality of LifePilonidal Cyst/FistulaNCT03757572Larissa University Hospital65