PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Time to complete healing of the burn
研究概览
简要总结
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.
详细描述
After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Study participants admitted within 72 hours of injury
- •partial-thickness burns requiring a temporary skin cover
- •written informed consent
排除标准
- •severe coexisting cutaneous trauma
- •chronic or current skin disease,
- •severe cognitive dysfunction or psychiatric disorder
- •pregnant or breast feeding women were excluded.
结局指标
主要结局
Time to complete healing of the burn
时间窗: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.
次要结局
- Burn wound infection(Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months)
- Burn scar outcome(Evaluated at six and 12 months after injury)
- Burn wound pain(Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months)
- Duration of hospital stay (LOS)(From admission until discharge, up to 6 months)
研究者
Folke Sjoberg
Professor in burn care
University Hospital, Linkoeping