The way out of the vacuum of evidence!

A decision of the Federal Joint Committee, that is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany, states that negative pressure wound therapy is not accepted as a standard therapy with full reimbursement by the health insurance companies in German outpatient care.

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 study projects that an insufficient state of evidence regarding the use of negative pressure wound therapy (NPWT) for treatment of acute and chronic wounds exists.

The independent scientific “Institute for Research in Operative Medicine” (IFOM) as part of the University of Witten / Herdecke performs the SAWHI-study

to evaluate the efficacy and effectiveness of NPWT for the treatment of subcutaneous abdominal wound healing impairment after surgery compared with standard conventional wound therapy. The study is supported and fully financed by the manufacturer Kinetic Concepts Incorporated (KCI) / Acelity.

The aim of the study is to compare the clinical, safety and economic results of both treatment arms and to generate solid evidence regarding the efficacy of NPWT, which may contribute to the final decision of the Federal Joint Committee Germany on reimbursement.

Further information

• ClinicalTrials.gov: NCT01528033
• German Clinical Trials Register: DRKS00000648

Publications

• Trials.2013, 14:394
• Der postoperative Wundinfekt: Diagnose, Klassifikation und Behandlung