jRCTs032180062已完成不适用
A specified clinical study for safety and usefulness of negative pressure closure for the stabilization of skin graft in wide or muscle-exposing defects (NPSG study)
未提供0 个研究点目标入组 8 人开始时间: 2019年8月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Factorial Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with defects in the trunk and extremities of >10 cm in size, or with muscle exposure.
排除标准
- •Defects with contraindication for negative pressure closure (defects with exposure of main vessels, organs or nerves. Defects with fissures connected with organs or untested fissures. Defects with liquorrhea or digestive system fistula, which are suspected to become severer by negative pressure closure. Defects with necrosis, osteomyelitis with osteonecrosis or apparent malignant tumor.) Dialysis patients, diabetic patients (HbA1c>8%), patients with systemic steroid therapies (>prednisolone 20mg/ day). Defects of which the fixation by negative pressure closure is difficult because of hubby surface of surrounding tissues. Defect with bone exposure. Cases in which the devices are possible to be broken because of difficulty of keeping the patient at rest. A patient who shows more than 2 skin defects that fit the inclusion criteria.
结局指标
主要结局
-
Safety
次要结局
- Graft survival(7 and 10 after surgery)
研究者
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