Dermal Substitution in Paediatric Burns: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scar quality (clinician)
研究概览
简要总结
The standard treatment of deep dermal to full thickness burns is surgical removal of the burn followed by skin transplantation. Dermal substitutes are increasingly used in the treatment of deep burns to replace lost dermis. Preservation of the collagen and elastin in the acellular human dermal substitute Glyaderm provides a more elastic scar. It is unknown what the effect of Glyaderm on scar quality is in a solely paediatric population.
The objective of this case series is to investigate scar maturation and scar quality when applying Glyaderm in deep dermal to full thickness burns in a pediatric population aged ≤15 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤15 years old
- •Burn wounds requiring skin grafting
- •Written informed consent provided by
- •The participant's parent(s)/guardian (<12 years of age)
- •The participant's parent(s)/guardian and the participant itself (12-15 years old)
排除标准
- •Burn wound of ≤30 cm2
- •Infected burn wounds: clinical symptoms in combination with positive wound swabs
- •Patients/parents with insufficient knowledge of the Dutch or English language, since they would not be able to complete the POSAS questionnaire.
结局指标
主要结局
Scar quality (clinician)
时间窗: 12 months
Scar quality measured using the Patient and Observer Scar Assessment Scale (POSAS) Observer Scale, which rates the scar from 1 (=like normal skin) to 10 (=worst scar imaginable).
次要结局
- Clinical assessment of the graft take(5-7 days after STSG application)
- Wound healing time(determined in the first several days to weeks after STSG application)
- Wound epithelialization(5-7 days after STSG application)
- Occurrence of scar hypertrophy(Up to 12 months post-surgery)
- Range of motion of affected joints(3, 6 and 12 months post-surgery)
- Scar surface area(day of surgery (day 0) and 3, 6 and 12 months post-surgery)
- Occurrence of scar contractures(Up to 12 months post-surgery)
- Donor site healing time(determined in the first several days to weeks after STSG application)
- Scar quality (participant)(3, 6 and 12 months post-surgery)