Negative-pressure wound therapy versus standard treatment of adult patients with conflict-related extremity wounds: Protocol for a randomized controlled trial

Abstract

Background: In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up. Objective: The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds. Methods: This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat. Results: The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019. Conclusions: To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies.