Background of this investigator initiated clinical trial is the decision of the Joint Federal Committee of Germany (Gemeinsamer Bundesausschusses (G-BA)) that Vacuum assisted closure therapy (Negative Pressure Wound Therapy [NPWT]) in outpatient care is inadmissible to be a standard benefit of health insurance companies in Germany.
This decision is based on systematic review & meta-analysis of existing trials performed by Institute for Quality and Economic Efficiency in the Healthcare System (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)) which showed an insufficient state of evidence regarding the efficacy of negative pressure wound therapy for the treatment of acute and chronic wounds.
The study aims to show that using V.A.C.® Therapy is an effective and safe treatment option for hospitals as well as for outpatient care for treatment of subcutaneous abdominal wounds with wound healing impairment in the postoperative course.
Study Outline
This study project compares Vacuum Assisted Closure® and standard conventional wound therapy (SCWT) in the treatment of acute abdominal wounds after surgery without fascial dehiscence and will be conducted in abdominal surgical hospital departments with the required structural, manpower, and scientific qualifications. Patients will be stratified according to hospital and wound size. Trial therapy will be started in-hospital and may be continued in ambulatory care.Primary Objective
The study is designed as a multinational, multicentre, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. The primary objective is to compare the clinical, safety, and economic outcomes of V.A.C.® Therapy and SCWT in postsurgical abdominal wound healing impairments without fascial dehiscence. The primary outcome to be observed in this study is time to complete abdominal wound closure within a maximum study treatment time of 42 days and confirmed to have been sustained for a period of at least 14 consecutive days. This study design also will allow detailed description of specific covariates to determine their effect on response variables (healing). This study’s hypothesis is that the use of the V.A.C.® Therapy System, when compared to SCWT in the management of post-surgical abdominal wound healing impairments with intact fascia, will result in a decrease in the time to achieve complete wound closure with confirmation after subsequent 14 days.The study aims to show that using V.A.C.® Therapy is an effective and safe treatment option for hospitals as well as for outpatient care for treatment of subcutaneous abdominal wounds with wound healing impairment in the postoperative course.