[Negative Pressure Wound Therapy: Randomised Controlled Trials from 2000 to 2015]

Background Negative pressure wound therapy is believed to promote wound healing. However, the results from randomised controlled trials (RCTs) are inconsistent. Systematic reviews indicate unclear evidence, due in part to low-quality RCTs, calling for more RCTs of higher quality. Methods This study aimed to ascertain the number of RCTs as well as systematic reviews on RCTs published during the time period from 2000 to 2015. Various search strategies were used to identify studies in PubMed, Cochrane Library, Google, references lists of retrieved articles, and institutions that issue evidence reports. The study also aimed to investigate the quality of included RCTs. It evaluated whether or not the randomisation methodology was comprehensibly described and conclusions were based on acceptable endpoints. Results The search for studies resulted in 456 different references, which included a total of 49 RCTs and 81 systematic reviews. Randomisation was comprehensibly described in 37% (18 out of 49 RCTs) and concealment of allocation in 10% (5’out of 49 RCTs). Conclusions were based on acceptable endpoints in 55% (27 out of 49 RCTs). A superior efficacy of NPWT versus standard was stated in 65% (32 out of 49 RCTs). In studies based on acceptable endpoints, this proportion was 16% (8 out of 49 RCTs). Systematic reviews repeatedly included identical study data. Conclusion The published literature, reviewed over a period of more than 16 years, contains more systematic reviews incorporating secondary data from other RCTs than actual RCTs reporting primary clinical data. Many RCTs seem to be of low quality, which considerably limits the validity of the corresponding conclusions. The ongoing production of potentially unreliable RCTs and redundant systematic reviews does not seem to provide convincing answers to crucial clinical research questions. Therefore, a change in strategy should be contemplated to observe individual characteristics of the respective persons and the wounds in question.