跳至主要内容
临床试验/DRKS00000648
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

发起方
Private Universität Witten/Herdecke gGmbHFakultät für Gesundheit

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