手术无筋膜裂开后皮下腹部伤口愈合障碍的真空辅助闭合治疗（SAWHI-V.A.C.®研究）与标准常规伤口治疗的比较：一项随机对照试验的研究方案。
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: study protocol for a randomized controlled trial.
机构信息
IFOM - Institute for Research in Operative Medicine, Faculty of Health - School of Medicine, University of Witten/Herdecke, Ostmerheimer Strasse 200, Building 38, 51109, Cologne, Germany.
出版信息
Trials. 2013 Nov 20;14:394. doi: 10.1186/1745-6215-14-394.
BACKGROUND
A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, 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 for the treatment of acute and chronic wounds exists. Further studies were therefore indicated.
METHODS/DESIGN: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms.
DISCUSSION
The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. 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.
TRIAL REGISTRATION
Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.
背景
2008 年联邦联合委员会德国的一项决定指出，负压伤口疗法不能被德国的健康保险公司接受作为标准疗法全额报销。这一决定是基于 2006 年德国卫生保健质量与效率研究所的最终报告，该报告通过对先前研究项目的系统评价和荟萃分析表明，在使用负压伤口疗法治疗急性和慢性伤口方面，证据不足。因此需要进一步研究。
方法/设计：该研究设计为一项多国家、多中心、前瞻性、随机对照、适应性设计的临床优效性试验，对主要终点进行盲法摄影分析。评估负压伤口疗法在医疗和非医疗领域（门诊和住院）的伤口中的疗效和效果。该试验将比较基于负压伤口疗法原理的技术医疗设备（干预组）与标准常规伤口疗法（对照组）在治疗手术后皮下腹部伤口的治疗效果。SAWHI-VAC®研究的目的是比较两种治疗方法的临床、安全性和经济学结果。
讨论
该研究项目旨在提供关于负压伤口疗法疗效的有力证据。研究结果将于 2014 年底前提供，为联邦联合委员会德国最终决定将负压伤口疗法作为医疗领域的标准疗法提供依据。
试验注册
ClinicalTrials.gov NCT01528033German Clinical Trials Register DRKS00000648。
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