A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Graft take (experimental vs control area)
研究概览
简要总结
In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.
详细描述
Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥18 years
- •with acute burns/trauma wounds that require skin grafting (group 1) OR
- •with scar problems requiring surgical treatment (group 2)
- •Full thickness skin defects of 50 cm2 or more, but <50% TBSA
- •Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
- •Informed consent by the patient
排除标准
- •Patients with infected wounds
- •Pregnant or breast feeding females
- •Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
- •Known allergy against porcine collagen or elastin
- •Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
- •Previous enrolment of the patient into the current study
结局指标
主要结局
Graft take (experimental vs control area)
时间窗: 5-7 days postoperative
Subjective assessment of two experienced observers
次要结局
- Complication rate(Up to 12 months postoperative)
- Epithelialization(5-7 and 18 ± 2 days days postoperative)
- Scar quality(12 months)