A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 5
- 主要终点
- Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
研究概览
简要总结
In this study the efficacy 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. The investigators expect this treatment 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. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) 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)
盲法说明
participant and assessor are both unaware of location of dermal template
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 (for Zurich: ≤ 18 years)
- •Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
- •≤ 50% TBSA full thickness skin defects at time of intervention
- •Informed consent by the patient and/or legal representatives.
排除标准
- •Patients with infected wounds
- •Full thickness skin wounds located in face and/or genitals will not be included
- •Pregnant or breast feeding females
- •Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
- •Known allergy against porcine collagen or elastin
- •Patients that are expected (according to the responsible medical doctor) to be non-compliant 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
Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
时间窗: 3 months post-operative
Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
次要结局
- Graft take (Subjective assessment by experienced observer)(5-7 days)
- Epithelialisation (Subjective assessment by experienced observer)(5-7 days and 2-3 weeks post-operative)
- Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)(12 months)
- Scar quality (As determined with subjective scar assessment scale (POSAS)(3 and 12 months)
- Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)(3 and 12 months)