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临床试验/NCT04583605
NCT04583605Unknown不适用

Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年1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
90
试验地点
1
主要终点
Is there a visible scar disunion ?

研究概览

简要总结

In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.

详细描述

Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • major patient affected by a metastatic skin tumors
  • the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor

排除标准

  • lymph node dissection resumption

结局指标

主要结局

Is there a visible scar disunion ?

时间窗: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end

Yes if there is a scar opening, no if there isn't

Is there lymphorrhoea from the scar ?

时间窗: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end

Yes if there is lymph coming from the the scar, no if there isn't.

次要结局

  • Are there lymphocele punctures ?(between day 1 and day 7, between day 7 and day 30, between day 30 and first year end)
  • Is there any lymphoedema ?(between day 1 and day 7, between day 7 and day 30, between day 30 and first year end)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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