Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial

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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12334.