NCT01824381已完成1 期
Use of the Amniotic Membrane in Large Wound Epithelialization. Phase I Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute wounds in granulation phase with a minimum area of 100 cm
- •Patients 18 or more years.
- •Patients offering sufficient guarantees of adherence to protocol.
- •Sign the written informed consent.
- •Meet all inclusion criteria.
排除标准
- •Patients with symptomatic chronic arterial insufficiency.
- •Patients who are pregnant
- •Patients in active lactation
- •Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
- •Complete abstinence from sexual intercourse
- •Surgical sterilization (tubal ligation)
- •Surgical sterilization of the partner (vasectomy)
- •Implanted or injectable hormonal contraceptives, oral *
- •Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control.
- •These reliable contraception must be maintained during their participation in the study.
- •Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test.
- •Participation in other clinical trials.
- •Inability to understand informed consent.
研究组 & 干预措施
Amniotic membrane in large wounds
Experimental
干预措施: Place amniotic membrane in large wounds (Procedure)
Amniotic membrane in large wounds
Experimental
干预措施: Obtaining and Cryopreservation of amniotic membrane (Procedure)
Amniotic membrane in large wounds
Experimental
干预措施: amniotic membrane (Drug)
结局指标
主要结局
Safety
时间窗: Last revision at 3 years after surgery.
No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes.
次要结局
- Measurement of the wound area(3 years)
- Evolution of local pain measured with a visual analog scale(1 year)
- Changes in the signaling pathways of TGFb.(1 year)
研究者
研究点 (1)
Loading locations...
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