PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change of percentage of wound healing after 1 week, 2 weeks and 3 weeks.
研究概览
简要总结
PRF Based Dressing Versus AQUACEL® for Local Treatment of Skin Graft Donor Site: A Non-Inferiority Trial
详细描述
A prospective single-blind study, where the evaluator is blinded to the treatment. Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.
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
盲法说明
Each patient will be dressed with both Aquacel® and PRF dressing. Half of the donor site area will be dressed with PRF dressing, and half with Aquacel®.
3 days after surgery the patients will be asked to complete a VAS questionnaire. A week and 2 weeks after surgery, patients will have their dressing changed as in the first treatment, and will answer VAS(9) and bluebelle(10) questionnaires. The wound will be photographed again for follow-up. Three weeks, 6 weeks and 3 months after surgery the scar in the donor area will be evaluated. The photographs will be shown to the blinded evaluator, to evaluate wound healing by epithelialization estimation.
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
- •Patients with a small burn (2-20% TBSA), who require skin grafting.
排除标准
- •Patients younger than 18 years
- •Patients refusing hospitalization
- •Patients with heavily infected wounds, which are the probable cause of bacteremia or sepsis.
- •Patients with diabetes mellitus or peripheral vascular disease
- •Patients under treatment of steroids or other immunosuppressing agents
- •Patients with infectious diseases, i.e., HIV, HCV or HBV.
- •Patients who are smokers.
- •Patients with a known allergy to the dressing.
- •Female patients who are pregnant or nursing, psychiatric patients and soldiers.
结局指标
主要结局
Change of percentage of wound healing after 1 week, 2 weeks and 3 weeks.
时间窗: 3 weeks
Primary variables will be analyzed using ImageJ software.
次要结局
未报告次要终点
研究者
Yehuda Ullmann MD
Professor
Rambam Health Care Campus