Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Need for autograft application
研究概览
简要总结
The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.
详细描述
We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥18 years and ≤75 years
- •Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
- •TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
- •TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
- •Subject is able and willing to sign Informed Consent or via legally authorized representative
排除标准
- •Study Wound due to electrical, radioactive, or frostbite-related injury
- •Infection of wounds in the study area at admission per Investigator or treating physician discretion
- •Pregnancy/lactation
- •Subjects who are unable to follow the protocol or who are likely to be non-compliant
- •Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
- •Prisoners
- •Life expectancy less than 6 months
- •Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment
研究组 & 干预措施
Suprathel® dressing
The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use
干预措施: Suprathel® (Other)
Standard of Care
The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.
干预措施: Suprathel® (Other)
结局指标
主要结局
Need for autograft application
时间窗: 21 days
The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.
次要结局
- Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).(Mid (3-9 months) and long term (52 weeks))
- Patient-reported perception of pain based on the Visual Analog Scale(After initial application (Day 0) and weekly)
- Wound infection rate, wound closure of the region(2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart))