NCT03669406Unknown不适用
Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.
Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Rate of recurrence of eschar
研究概览
简要总结
Autografting of fat cells is widely used in plastic surgery in breast reconstruction, burn scars, unsightly scars etc. It is known that the autografting of fat cells not only makes it possible to bring adipocytes, and thus to create a volume, but also promotes neo-angiogenesis by providing the growth factors which allows an improvement of the local cutaneous tissue.
Currently the investigators perform this action in their service on healed eschars, by analogy with burn scars that are also dystrophic, so as to improve cutaneous trophicity, and reduce the recurrence of eschars on these scars. However, the literature on the autografting of fat cells on eschars is limited.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 and 65 years old;
- •presenting a medullary, post-traumatic or congenital lesion, with consequent paraplegic sequelae;
- •With a history of eschar:
- •Pelvic (ischiatic, trochanteric or sacral),
- •Healed for at least 6 months, after surgical treatment or directed healing (scarring is defined by the absence of local care, ie no nursing care);
- •Affiliated to a social security ;
- •Written informed consent.
排除标准
- •Patient malnourished (albuminemia <40g / L);
- •Non-weaning or weaned tobacco addiction for less than 3 weeks (compared to the date of surgery);
- •Contraindication to MRI ;
- •Protected person subject to legal protection (legal safeguards, guardianship, trusteeship), person deprived of liberty,
- •Pregnant woman.
结局指标
主要结局
Rate of recurrence of eschar
时间窗: 12 months
次要结局
- Vancouver score(12 months)
- POSAS scale score(12 months)
- Improvement Vancouver score(12 months)
- Evaluation of neovascularization(12 months)
- Analysis of the stromal vascular fraction of the injected fat(12 months)
- Time of occurrence of recurrence of eschar (censored criterion)(12 months)
- Number of recurrence of eschar(12 months)
- Volumetric assessment(12 months)
- Analysis of pro-angiogenic genes expressed in the stromal vascular fraction of the injected fat(12 months)
研究者
研究点 (1)
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