NCT01285973已完成不适用
Evaluation of Integra® Artificial Dermis for the Treatment of Leg Ulcers
Integra LifeSciences Services3 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2011年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.
研究概览
简要总结
The aim of this prospective study is to assess the utility of treatment of leg ulcers using a skin substitute, Integra®, assessing the quality of wound skin healing and transcutaneous oxygen pressure in the distal region of the wound.
This is a multi-centre study on 60 patients who have a lower limb ulcer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with a lower limb ulcer, regardless of origin (arterial, venous or mixed, diabetic foot ulcer) present for more than 6 months or large in size (> 10 cm²)
- •patients in whom the surgeon has recommended that an Integra® matrix be implanted (even if the patient is not taking part in the study) before the dermo-epidermal graft to obtain a richly vascularised neodermis.
- •not eligible for skin flap surgery,
- •the patient or patient's representative has agreed to sign the information letter before any investigation required by the research.
排除标准
- •circumferential wound,
- •wound infection
- •immunosuppressed patient,
- •known allergy to bovine collagen, bovine glycosaminoglycans or silicone,
- •patients under legal guardianship,
- •pregnant women
- •patients whose health would compromise follow-up for at least 18 months,
- •patients whose mental health would compromise completion of the self-evaluation questionnaires.
- •wound located in an area not visible by the patient (as no self-assessment would be possible).
结局指标
主要结局
Proportion of patients with a greater than 50% reduction in wound surface area during the 18 months after grafting.
时间窗: 18 months
次要结局
- Complete wound healing (reduction in wound surface area >90%)(3, 6, 12, 18 months)
- Quality of life(3, 6, 12, 18 months)
- Functional complications of healing at 3, 6, 12 and 18 months(3, 6, 12 and 18 months)
- Pain(3, 6, 12, 18 months)
- Transcutnaeous oxygen pressure (TcPO2)(6, 12 and 18 months)
研究者
研究点 (3)
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