DRKS00000648已完成未知
Treatment of Subcutaneous Abdominal Wound Healing Impairment after surgery without fascial dehiscence by Vacuum Assisted Closure™ (SAWHI–V.A.C.® Study) versus standard conventional wound therapy - SAWHI–V.A.C.®
Private Universität Witten/Herdecke gGmbHFakultät für Gesundheit0 个研究点目标入组 539 人开始时间: 2011年10月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 539
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Written informed consent / Post-surgical subcutaneous abdominal wound healing impairment / Minimum wound size eligible for the application of the randomized treatment / Inclusion, randomization, adequate wound pre-treatment (Debridement)
- •and start of therapy within 48 hours after reopening of the wound, diagnosis for nonclosable wound or in case of spontaneous wound dehiscence
排除标准
- •Age < 18 years / Noncompliance with study procedures, visit schedule and follow up / Pregnancy / Present or nonclosable defect of the abdominal fascia/ Any pre-existing or ongoing organ system failure, that cannot be stabilized or solved by appropriate medical treatmen / Necrotic tissue with eschar present / Non-enteric and unexplored fistulas / Malignancy of the wound / Elevated intra-abdominal tension over the normal range with existing or foreseeable dysfunction of organs / Use of any other suction device on the study wound within = 8 days prior
- •to screening / Competing therapies or procedures / Simultaneous participation in other clinical trials
研究者
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