Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Time to complete wound closure
研究概览
简要总结
Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.
详细描述
Aim: The aim of this study was to compare two different treatment regimes for children with partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®, Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke Health Care, Gothenburg, Sweden).
Methods: A prospective randomized clinical trial including 58 children admitted between May 2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden. Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery, wound infection, length of hospital stay, required dressings changes, and labour time.
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
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partial-thickness scald burns admitted within 72 hours of injury and with burns suitable for porcine xenograft according to the burn surgeon on duty were eligible and enrolled after (guardians) consenting to participate.
排除标准
- •Children with other severe concomitant cutaneous trauma, skin disease, or children with a known hypersensitivity to silver.
结局指标
主要结局
Time to complete wound closure
时间窗: Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)
Calculated from the date of injury to the date when the wound bed was assessed as completely reepithelialized with no necessity for further wound dressings other than a protective dressing against shearing, according to both the attending physician and nurse
次要结局
- Pain (at wound site)(Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
- Need of surgery(Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
- Burn wound infection(Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
- Length of hospital stay(Evaluated after complete wound closure, approximatley 15-20 days after injury.)
- number of dressing changes required(Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
- adverse events(Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
- Minutes needed for application and removal of dressing(Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.)
研究者
Folke Sjoberg
Professor
University Hospital, Linkoeping