NCT01704950已完成不适用
Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Integra LifeSciences Services4 个研究点 分布在 4 个国家目标入组 52 人开始时间: 2013年2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
- 52
- 试验地点
- 4
- 主要终点
- Rate of graft take
研究概览
简要总结
The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)
- •Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure
- •Wound treated with only one layer of a maximum size 10cm*12.5cm
排除标准
- •Immunosuppressed patient
- •Chronic wound (with no healing since 6 months)
- •Addition of any substances (growth factor, stem cells,...) in the IDRT SL during the surgery
- •Patient with a corticoid treatment with a daily dose greater than 5 mg
- •Patients whose life expectancy is less than 12 months
- •Patients whose mental health or health condition (Visual deficiency, Alzheimers...) would compromise completion of the self-evaluation questionnaires
- •Patient with an hypersensitivity to bovine collagen, chondroitin
- •Patient with clinical signs of infection (fever, pain, colour, swelling,...) and for whom the investigator diagnosed infection
结局指标
主要结局
Rate of graft take
时间窗: Day 15 after the surgery
the mean percentage of healing expected at Day 15 after the surgery
次要结局
未报告次要终点
研究者
研究点 (4)
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