Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Efficacy as measured by speed of wound healing
研究概览
简要总结
This study is a randomized, controlled, multi-centre, open-label, phase IV study.
Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who is same as or more than 19 years old
- •Patients who will receive elective skin harvest operation
- •Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
- •Female patients who use method of contraception for the study
- •Patients who voluntarily sign the informed consent
排除标准
- •Patients who are pregnant
- •Patients who are known to have allergy to the dressing product including PVPI
- •Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
- •Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c > 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
- •Patients who receive anticoagulants, steroids or immunosuppressants
- •Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
- •Patients who have skin lesion such as Herpes zoster on donor site
- •Burn of >20% total body surface area
- •If the donor site had been harvested on a previous occasion
- •Patients who is limited cognitive ability
- •Patients who are participating in or will plan to participate in other clinical trials
- •Other various conditions that the investigators judge inappropriate for enrolment
研究组 & 干预措施
Allevyn Wound Dressing
Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.
干预措施: Allevyn Wound Dressing (Device)
Betafoam Wound Dressing
This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.
干预措施: Betafoam Wound Dressing (Device)
Petrolatum Gauze
Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.
干预措施: Petrolatum Gauze (Device)
结局指标
主要结局
Efficacy as measured by speed of wound healing
时间窗: 6 months
Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds
次要结局
- Efficacy as measured by adverse event collection(6 months)