Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Wound Healing Rate (Re-epithelialization)
研究概览
简要总结
The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Inpatient status at study site
- •Subject must be receiving a split-thickness skin graft (STSG)
- •Wounds must not exceed 10% total body surface area (TBSA)
- •Any donor site
- •Ability to comply with necessary wound care/follow up
排除标准
- •Subject is pregnant
- •Subject has been diagnosed with Diabetes
- •Subject is a smoker
- •Subject takes steroids
- •Subject is sensitive and/or allergic to shellfish and/or silver
- •Wounds that exceed 10% total body surface area (TBSA)
- •Inability to comply with necessary wound care/follow up
研究组 & 干预措施
Opticell Ag
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination.
干预措施: Opticell Ag (Device)
结局指标
主要结局
Wound Healing Rate (Re-epithelialization)
时间窗: Assessed up to 1 month postoperatively.
The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.
Pain
时间窗: Assessed up to 14 days of use
Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.
次要结局
- Wound Healing Quality(Assessed up to 1 month of use)
研究者
Indranil Sinha
Assistant Professor of Surgery, Harvard Medical School, Division of Plastic Surgery
Brigham and Women's Hospital