The Effect of Adipose Tissue Extract and Platelet-rich Plasma on Split-thickness Donor Site Wound Healing. A Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Wound Re-epithelization
研究概览
简要总结
Adipose Tissue Extract (ATE) has been found to be an autologous source of growth factors with proven in vitro angiogenic and adipogenic properties.It is obtained by a simple lipoaspirate procedure. We sought to compare the effect of ATE with another known source, platelet-rich plasma to compare the wound healing characteristics on skin graft donor sites.
详细描述
The investigators enrolled 24 participants with an indication for skin graft. Two or more split-thickness grafts are harvested per patient, one serving as control and the other as experimental. The experimental sites were covered with either autologous PRP gel or ATE prepared in the OR, which was selected in an unblinded manner due to surgical theater convenience. However, donor sites were randomized through a computer generator. Covered with a semiocclusive film, wounds were separated and followed up on days 3,5,7,10,14 for wound healing and 30 and 60 for scar evaluation. Digital photography and specto-photocutometry was employed to know the hemoglobin and melanin content of the wounds, and custom-made software was used to calculate the percentage of wound re-epithelialization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •donor site indication
排除标准
- •immunosupressive states
- •terminal renal insufficiency
- •pregnancy
- •coagulation dyscrasias
- •active infection in donor site
结局指标
主要结局
Wound Re-epithelization
时间窗: 30 days
observational-digital photography with specialized custom-made software
次要结局
- Melanin Concentration in Wound(day 30 and 60)
- Scar Properties(30 and 60 days)
- Oxygenated Hemoglobin(day 30 and 60)
研究者
Jenny Lopez
Medical Doctor
Tampere University