Artikel
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
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Autoren
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Dörthe Seidel
- Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH, Zentrum für Klinische Studien und Innovation, Köln
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Stefanie de Lange
- Institut für Forschung in der Operativen Medizin der Privaten Universität Witten / Herdecke gGmbH, Zentrum für Klinische Studien und Innovation, Köln
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Rolf Lefering
- IFOM - Institut für Forschung in der Operativen Medizin - Universität Witten/Herdecke gGmbH, Fakultät für Gesundheit (Dept. für Humanmedizin), Köln
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Edmund Neugebauer
- IFOM - Institut für Forschung in der Operativen Medizin - Universität Witten/Herdecke gGmbH, Lehrstuhl für Chirurg. Forschung u. Prodekan Forschung, Fakultät für Gesundheit, Dept. Humanmedizin, Köln
| Veröffentlicht: | 26. April 2013 |
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Gliederung
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Introduction: A decision of the Federal Joint Committee Germany states that negative pressure wound therapy is not accepted as a standard therapy with full reimbursement by the health insurance companies in Germany. This decision is based on the rapid report and the final report of the Institute for Quality and Efficiency in Health Care, which demonstrated through systematic reviews and meta-analysis of previous studies projects that an insufficient state of evidence regarding the use of negative pressure wound therapy for treatment of acute and chronic wounds exists.
Material and methods: This multinational, multicenter, randomized controlled, clinical superiority trial uses an adaptive trial design with a planned interim analysis and a maximum number of 552 participants to be analyzed. The treatment outcome of Vacuum Assisted Closure®- (V.A.C.®-) Therapy manufactured by Kinetic Concepts Incorporated (KCI) will be evaluated in comparison to standard conventional wound therapy in the treatment of acute subcutaneous abdominal wounds after surgery. Study therapy starts in-hospital and may be continued in ambulatory care. The aim of this trial project is to compare the clinical, safety and economic results of both treatment arms.
Results: This multicenter study is conducted in qualified abdominal surgical hospital departments in Germany, the Netherlands, Belgium, United Kingdom and Austria. Patient recruitment started in August 2011.The presentation on the 130. Congress of the surgical society Germany in Munich informs about the actual status of recruitment and participating centers.
Conclusion: The independent scientific “Institute for Research in Operative Medicine” (IFOM) as part of the University of Witten / Herdecke gGmbH is responsible for the planning, implementation, analysis and publication of the trial project. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors.
