PMID- 30478024
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 7
IP  - 11
DP  - 2018 Nov 26
TI  - Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With 
      Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial.
PG  - e12334
LID - 10.2196/12334 [doi]
LID - e12334
AB  - 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.
CI  - (c)Andreas Alga, Sidney Wong, Rawand Haweizy, Kalle Conneryd Lundgren, Johan von 
      Schreeb, Jonas Malmstedt. Originally published in JMIR Research Protocols 
      (http://www.researchprotocols.org), 26.11.2018.
FAU - Alga, Andreas
AU  - Alga A
AUID- ORCID: 0000-0001-5245-7668
AD  - Department of Clinical Science and Education, Sodersjukhuset, Karolinska 
      Institutet, Stockholm, Sweden.
AD  - Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
FAU - Wong, Sidney
AU  - Wong S
AUID- ORCID: 0000-0002-3283-2798
AD  - Operational Centre Amsterdam, Medecins Sans Frontieres, Amsterdam, Netherlands.
FAU - Haweizy, Rawand
AU  - Haweizy R
AUID- ORCID: 0000-0003-0372-1500
AD  - Emergency Management Center, Erbil, Iraq.
FAU - Conneryd Lundgren, Kalle
AU  - Conneryd Lundgren K
AUID- ORCID: 0000-0001-6781-762X
AD  - The Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden.
FAU - von Schreeb, Johan
AU  - von Schreeb J
AUID- ORCID: 0000-0002-5331-3305
AD  - Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.
FAU - Malmstedt, Jonas
AU  - Malmstedt J
AUID- ORCID: 0000-0002-2758-9623
AD  - Department of Clinical Science and Education, Sodersjukhuset, Karolinska 
      Institutet, Stockholm, Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT02444598
PT  - Journal Article
DEP - 20181126
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC6288590
OTO - NOTNLM
OT  - extremity wounds
OT  - negative-pressure wound therapy
OT  - resource-limited settings
OT  - war-related injuries
COIS- Conflicts of Interest: None declared.
EDAT- 2018/11/28 06:00
MHDA- 2018/11/28 06:01
PMCR- 2018/11/26
CRDT- 2018/11/28 06:00
PHST- 2018/09/27 00:00 [received]
PHST- 2018/10/25 00:00 [accepted]
PHST- 2018/11/28 06:00 [entrez]
PHST- 2018/11/28 06:00 [pubmed]
PHST- 2018/11/28 06:01 [medline]
PHST- 2018/11/26 00:00 [pmc-release]
AID - v7i11e12334 [pii]
AID - 10.2196/12334 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2018 Nov 26;7(11):e12334. doi: 10.2196/12334.