Background of the study is the decision of a German authority, which is responsible for the reimbursement of medical therapies (Joint Federal Committee of Germany), that outpatient Vacuum assisted closure therapy is inadmissible to be a standard benefit of health insurance companies in Germany.
Basis for this decision have been reports of the Institute for Quality and Economic Efficiency in the Healthcare System, which showed an insufficient state of evidence regarding the efficacy of negative pressure wound therapy for the treatment of acute and chronic wounds.
The central analyzing personal will not be informed about patient details or therapy allocation.
Study Outline
This study will be performed in several hospitals and countries to compare the efficacy of Vacuum Assisted Closure®-therapy with the methods of standard conventional wound therapy according to the existing hospital standard. Main outcome measure is the time which is needed to achieve a complete and stabile wound closure. Furthermore the therapy options will be examined regarding several other clinical, safety, patient reported and economic parameters.Treatment Groups
Patients will be assigned equally and by chance to both treatment groups. Study participants as well as the attending doctors and nurses will be informed about the assignment to the respective treatment arm.Outcome Measure
The primary outcome measure (time until complete and confirmed wound closure) and some of the secondary parameters like reappearance of the wound and the development of the wound size over time, examined within an active study treatment time of 42 days, will be photographed and analyzed using a central computer system.The central analyzing personal will not be informed about patient details or therapy allocation.