Evaluation of Silverlon Dressing for 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
- 17
- 试验地点
- 2
- 主要终点
- Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform
研究概览
简要总结
The purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned.
Hypothesis: The mean healing time for wounds treated with the Silverlon Dressing will be less than the mean healing time for wounds treated with Xeroform Dressing.
详细描述
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. Once the grafts have been harvested, the wounds will be randomized for treatment using either the Silverlon dressing or Xeroform. The wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older; male or female.
- •Burn wounds of less than 30% total body surface area (TBSA) with no systemic abnormalities
- •Burns do not involve the harvesting area
- •Burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- •Scheduled excision and grafting procedures is the first such operation for subject during this hospitalization
- •Subject agrees to participate in follow-up evaluations
排除标准
- •Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- •Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- •Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep vein thrombosis (DVT) prophylaxis.
- •Cellulitis or other infection of potential donor site
- •Previously harvested donor site
- •Subject with greater than 30% TBSA burns
- •Subjects with sensitivity to silver or nylon
- •Pregnancy
结局指标
主要结局
Pain will be less than or equal to with the Silverlon Dressing as compared with Xeroform
时间窗: 14 days
Cosmetic effect of healing at post operative day 30-45 will be equal to or less than with Silverlon as compared with Xeroform
时间窗: 30-45 days
次要结局
- Infections associated with donor sites will be equal to or less than with Silverlon as compared with Xeroform(14 days)