@Article{info:doi/10.2196/12334,
author="{\"A}lg{\aa}, Andreas
and Wong, Sidney
and Haweizy, Rawand
and Conneryd Lundgren, Kalle
and von Schreeb, Johan
and Malmstedt, Jonas",
title="Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2018",
month="Nov",
day="26",
volume="7",
number="11",
pages="e12334",
keywords="war-related injuries; negative-pressure wound therapy; extremity wounds; resource-limited settings",
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. 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 ",
issn="1929-0748",
doi="10.2196/12334",
url="http://www.researchprotocols.org/2018/11/e12334/",
url="https://doi.org/10.2196/12334",
url="http://www.ncbi.nlm.nih.gov/pubmed/30478024"
}