Health technology assessment of the negative pressure wound therapy for the treatment of acute and chronic wounds: Efficacy, safety, cost effectiveness, organizational and ethical impact

Background: the aim of the study was to assess the safety, efficacy and cost-effectiveness of Negative Pressure wound therapy (NPT) for people with chronic and acute wounds. Methods: the scope and the final draft of the report have been submitted to the stakeholders (producers, payers and patients). Safety issues were addressed through a systematic review of the meta-literature. Efficacy was addressed through a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing NPT and other standard therapies in patients with chronic or acute lesions. Cost-consequence was analyzed through a systematic review of the existing studies. Results: we retrieved 19 studies, 13 of which were included in the meta-analysis. Many studies had biases that may have resulted in a better performance for NPT. NPT showed: a slightly shorter healing time (-10.4 days, p=0.001), with no heterogeneity, apart from one small study with very positive results, and 40% more patients healed (p=0.002, no heterogeneity). We identified 15 original research papers on NPT costs and cost per outcome. The costs-per-patienttreated varied from +29% to -60%, with several studies reporting savings for NPT. Conclusions: despite serious methodological flaws, the body of evidence available was sufficient to prove some clinical benefit of NPT in severe chronic and acute wound treatment. There is a need for independent and contextualized cost analyses.