Prospective, Randomized, Controlled Study of the Efficacy of a Silver-coated Nylon Dressing Plus Active or Sham Microcurrent for Healing Autogenous Skin Donor Sites
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time to Wound Healing
研究概览
简要总结
This single-center, prospective, randomized, and controlled study evaluated the efficacy of silver-coated dressing with active microcurrent in comparison to silver-coated dressing with sham microcurrent on wound-closure time for autogenous skin donor sites.
详细描述
The specific aims of the study are to evaluate the impact of active versus sham direct microcurrent application to silver nylon dressings in the treatment of donor sites for partial thickness thermal injuries. The primary endpoint is wound-closure time (re-epithelialization of 90% or more of wound surface). A secondary endpoint was infection. Exploratory assessments of clinical outcomes, including inflammation, and pain medication (type, dosage, route, timing) will also be conducted.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18-65 years of age
- •burn less than 30% total body surface area
- •burns not involving donor site area
- •you need skin grafting to cover burns
- •agree not to use other electronic devices that generate current during your study participation
- •agree to come back for follow up visits at least every other day after discharge from hospital until donor site is healed
排除标准
- •you have an illness that may affect how your wound heals such as diabetes, blood clotting disorder, cirrhosis, liver failure, peripheral vascular disease
- •you are taking medications that could affect how your wound heals such as steroids, Plavix, Coumadin
- •you have an infection of the skin or your bloodstream
- •you are pregnant or nursing
- •you are sensitive or allergic to silver or nylon
- •your burn wounds are more than 30% of your total body surface area
- •your site was previously harvested for grafting
- •you have an implantable pacemaker device
结局指标
主要结局
Time to Wound Healing
时间窗: 20 days
Time to 90% confluent reepitheliazation of donor site, as indicator of wound healing
次要结局
未报告次要终点