Vacuum seal therapy study
16.01.2012 12:18
Launch after 16 years of market launch
One option for treating poorly healing wounds is vacuum sealing therapy, which has been around since 1995 and goes back to Fleischmann et al in 1993. Since then, a vacuum sealing system with the trade name “VAC Therapy” (vacuum-assisted closure) has been used in clinical practice in Germany. As early as 2002, at the request of the IKK Federal Association in accordance with Section 135 Paragraph 1 SGB V, the G-BA advised them on statutory health care, then sought comments from the specialist public and in 2004 provided the Institute for Quality and Efficiency in Health Care (IQWiG) with one Evaluation of the benefits and medical necessity of vacuum sealing therapy for wounds: The resulting final report was then presented to the G-BA in 2006. In it, scientists from the Institute for Quality and Efficiency in Health Care (IQWiG) together with researchers from the Cologne Institute for Research in Operative Medicine (FOM) evaluated the most important available studies on this topic, finding 28 studies at the time, of which a total of almost 1,100 patients participated. Their conclusion at the time: The low quality of the studies did not allow any conclusion to be drawn as to whether vacuum sealing or negative pressure wound therapy is better for some patients or certain wounds than conventional wound treatment. However, because some examined studies indicated that the wound area was reduced more quickly through vacuum sealing therapy, which, according to IQWiG, would definitely mean a (small) advantage of vacuum sealing over conventional wound treatment, the institute considered further meaningful studies necessary in which the previous - and disadvantages of vacuum sealing should be examined. This was followed by the Federal Joint Committee (G-BA), which called for precisely these studies for the decision in its decision of February 13, 2008 as a prerequisite for the inclusion of this therapy in the outpatient service catalog of the health insurance companies.
Well, just 16 years after the market launch, the time has come: the first national study on vacuum therapy for chronic wounds has started. At the end of December, a 76-year-old diabetic woman suffering from chronic diabetic foot syndrome was treated for the first time with negative pressure wound therapy at the Karlsruhe Municipal Hospital, Department of Vascular and Thoracic Surgery. “We hope that by starting the inclusion of the first study patient in 2011, we will be able to complete the study on time in 2014,” says Prof. Dr. Martin Storck, Director of the Clinic for Vascular and Thoracic Surgery at the Karlsruhe Municipal Hospital. This means that everyone involved has finally agreed on the modalities and financing of a study whose aim is not only to examine the medical benefits of negative pressure wound therapy, but also to compare cross-sector and outpatient therapies. For this purpose, the Association of Replacement Funds e. V. (vdek), the AOK Federal Association and the Knappschaft jointly announced studies with a budget of around 1.6 million euros in July 2010. Since the AOK (http://www.aok-bv.de/gesundheit/versorgungsbereiche/index_03725.html) assumes total costs of 2.5 million euros, the treatment costs for vacuum sealing therapy in the outpatient sector are included here, while the manufacturers - KCI Medizinprodukte and smith & nephew - are supposed to bear the costs of the study.
A total of around 7,000 insured people are now being treated as part of a clinical study or as part of an integrated care contract. Patients with diabetes and chronic wounds in the foot area (diabetic foot) as well as patients with impaired wound healing in the abdominal area after a surgical procedure are included. The Institute for Research in Operative Medicine at the University of Witten-Herdecke, headed by Univ.-Prof. Dr. Edmund Neugebauer is responsible for the scientific conception and evaluation of this study. As a management company, the Leipzig Health Forums are responsible for all logistics.
After the study is completed in 2014, the G-BA will decide on the eligibility for reimbursement based on the results, because negative pressure wound therapy has not yet been approved in outpatient care as a standard therapy with full reimbursement by statutory health insurance companies.
Additional Information:
http://www.g-ba.de/informationen/beschluesse/510/
http://www.ted.europa.eu/udl?uri=TED:NOTICE:171649-2010:TEXT:DE:HTML&src=0
http://www.aok-bv.de/gesundheit/versorgungsbereiche/index_03725.html