Biosynthetic Skin Substitute Versus Frozen Human Cadaver Allograft for Temporary Coverage of Excised Full-thickness Burn Wounds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to heal
研究概览
简要总结
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.
详细描述
In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®.
30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas.
Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed.
Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors (healing time and scar assessments) are blinded.
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 2 % total body surface area (TBSA) full thickness burned.
- •Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.
排除标准
- •Time from injury to admission >= 5 days
- •Sepsis on admission or clinically suspected infection (as per attending physician)
- •Pregnancy or childbearing
- •Positive HIV or hepatitis screens
- •History of active malignancy
- •Patients who do not require surgical debridement and autografting
- •Patient with burn injuries originating from other causes (chemical, and frostbite)
结局指标
主要结局
Time to heal
时间窗: up to 8 weeks after initial grafting
Time until study areas are 95% healed, as rated by blinded assessors based on photographs
次要结局
- Incidence of adherence problems (Arm 1)(up to 21 days after initial surgery)
- Rate of fluid/hematoma accumulation(up to 21 days after initial surgery)
- Scarring with DermaLab Combo device: Viscoelasticity(Assessed between 9-15 months after initial admission)
- Scarring with DermaLab Combo device: Trans epithermal water loss(Assessed between 9-15 months after initial admission)
- Incidence of infections(up to 8 weeks after initial grafting)
- Scarring with DermaLab Combo device: Pigmentation(Assessed between 9-15 months after initial admission)
- Incidence of adherence problems (Arm 2)(up to 21 days after initial surgery)
- Cost effectiveness(Until grafting of study sites, within 21 days)
- Scar assessment with Patient and Observer Assessment Scale (POSAS)(Assessed between 9-15 months after initial admission)
- Scarring with DermaLab Combo device: Hydration(Assessed between 9-15 months after initial admission)