Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds

NCT02444598 | Completed DMC

• 1 other identifier: KISOS001
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 2

Brief Summary

There is a treatment method called negative-pressure wound therapy (NPWT) that is well established and used for the treatment of wounds. The method involves the application of a wound dressing through which a negative pressure is applied. Due to a plastic film overlaying the wound the risk of wound contamination is reduced. NPWT is considered to promote wound healing and prevent infection and has previously been used in the treatment of acute war associated wounds with satisfactory results. The aim of this study is to compare NPWT with conventional wound dressings in the treatment of war-associated extremity wounds and evaluate which method is more effective.

Conditions

Wounds, Gunshot; Arm Injuries; Leg Injuries; Wound Infection

Keywords

wounds; negative-pressure wound therapy; conflict; gunshot wound; blast injuries; civilian; war

Outcome Measures

Primary Outcomes (2)

• Early wound closure

  Wound closure, either by suture or split-thickness skin graft

  Day five +-1

• Cost-effectiveness comparing outcomes from NPWT and standard treatment

  Costs from the health care provider's perspective will be used. Cost-effectiveness will be expressed in US dollars.

  Days (between 1 and 50)

Secondary Outcomes (10)

• Rate of wound healing

  Days (between 1 and 50)

• Wound infection

  Days (between 1 and 50)

• Time until wound is deemed no longer requiring professional care

  Days (between 1 and 50)

• Time to discharge

  Days (between 1 and 50)

• Quality of life aspects

  Days five and eight

Study Arms (2)

Negative-pressure wound therapy

EXPERIMENTAL

Vaccum Assisted Closure device. Patients will receive negative-pressure wound therapy according to manufacturer treatment guidelines.

Device: Vaccum Assisted Closure device

Standard

ACTIVE COMPARATOR

Patients will be treated with conventional wound dressings according to local treatment protocols.

Procedure: Conventional wound dressings

Interventions

Vaccum Assisted Closure device DEVICE

Negative-pressure wound therapy

Negative-pressure wound therapy

Conventional wound dressings PROCEDURE

Conventional wound dressings

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years of age with extremity blast- or gunshot-wound(s). In case of multiple wounds the extremity wound with the estimated largest area is selected.

You may not qualify if:

• Wounds presenting \>72 hours following initial trauma.
• Wounds that are considered ready for primary closure by suture or split-thickness skin graft.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Medecins Sans Frontieres, Netherlands: collaborator
• Jordan University of Science and Technology: collaborator
• Stockholm South General Hospital: collaborator
• Center for Molecular Medicine: collaborator

Study Sites (2)

Emergency Hospital

Erbil, Kurdistan Region, Iraq

Location

Ar Ramtha Hospital

Ar Ramtha, Jordan

Location

Related Publications (19)

• Aboutanos MB, Baker SP. Wartime civilian injuries: epidemiology and intervention strategies. J Trauma. 1997 Oct;43(4):719-26. doi: 10.1097/00005373-199710000-00031.

  PMID: 9356079 RESULT

• Owens BD, Kragh JF Jr, Macaitis J, Svoboda SJ, Wenke JC. Characterization of extremity wounds in Operation Iraqi Freedom and Operation Enduring Freedom. J Orthop Trauma. 2007 Apr;21(4):254-7. doi: 10.1097/BOT.0b013e31802f78fb.

  PMID: 17414553 RESULT

• Fares Y, El-Zaatari M, Fares J, Bedrosian N, Yared N. Trauma-related infections due to cluster munitions. J Infect Public Health. 2013 Dec;6(6):482-6. doi: 10.1016/j.jiph.2013.05.006. Epub 2013 Jul 31.

  PMID: 23999350 RESULT

• Covey DC, Lurate RB, Hatton CT. Field hospital treatment of blast wounds of the musculoskeletal system during the Yugoslav civil war. J Orthop Trauma. 2000 May;14(4):278-86; discussion 277. doi: 10.1097/00005131-200005000-00010.

  PMID: 10898201 RESULT

• Krug E, Berg L, Lee C, Hudson D, Birke-Sorensen H, Depoorter M, Dunn R, Jeffery S, Duteille F, Bruhin A, Caravaggi C, Chariker M, Dowsett C, Ferreira F, Martinez JM, Grudzien G, Ichioka S, Ingemansson R, Malmsjo M, Rome P, Vig S, Runkel N, Martin R, Smith J; International Expert Panel on Negative Pressure Wound Therapy [NPWT-EP]. Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus. Injury. 2011 Feb;42 Suppl 1:S1-12. doi: 10.1016/S0020-1383(11)00041-6.

  PMID: 21316515 RESULT

• Machen S. Management of traumatic war wounds using vacuum-assisted closure dressings in an austere environment. US Army Med Dep J. 2007 Jan-Mar:17-23.

  PMID: 20084702 RESULT

• Peck MA, Clouse WD, Cox MW, Bowser AN, Eliason JL, Jenkins DH, Smith DL, Rasmussen TE. The complete management of extremity vascular injury in a local population: a wartime report from the 332nd Expeditionary Medical Group/Air Force Theater Hospital, Balad Air Base, Iraq. J Vasc Surg. 2007 Jun;45(6):1197-204; discussion 1204-5. doi: 10.1016/j.jvs.2007.02.003.

  PMID: 17543685 RESULT

• Leininger BE, Rasmussen TE, Smith DL, Jenkins DH, Coppola C. Experience with wound VAC and delayed primary closure of contaminated soft tissue injuries in Iraq. J Trauma. 2006 Nov;61(5):1207-11. doi: 10.1097/01.ta.0000241150.15342.da.

  PMID: 17099530 RESULT

• Ubbink DT, Westerbos SJ, Evans D, Land L, Vermeulen H. Topical negative pressure for treating chronic wounds. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD001898. doi: 10.1002/14651858.CD001898.pub2.

  PMID: 18646080 RESULT

• Webster J, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2014 Oct 7;(10):CD009261. doi: 10.1002/14651858.CD009261.pub3.

  PMID: 25287701 RESULT

• Peinemann F, Sauerland S. Negative-pressure wound therapy: systematic review of randomized controlled trials. Dtsch Arztebl Int. 2011 Jun;108(22):381-9. doi: 10.3238/arztebl.2011.0381. Epub 2011 Jun 3.

  PMID: 21712971 RESULT

• Bovill E, Banwell PE, Teot L, Eriksson E, Song C, Mahoney J, Gustafsson R, Horch R, Deva A, Whitworth I; International Advisory Panel on Topical Negative Pressure. Topical negative pressure wound therapy: a review of its role and guidelines for its use in the management of acute wounds. Int Wound J. 2008 Oct;5(4):511-29. doi: 10.1111/j.1742-481X.2008.00437.x. Epub 2008 Sep 19.

  PMID: 18808432 RESULT

• Hinck D, Franke A, Gatzka F. Use of vacuum-assisted closure negative pressure wound therapy in combat-related injuries--literature review. Mil Med. 2010 Mar;175(3):173-81. doi: 10.7205/milmed-d-09-00075.

  PMID: 20358706 RESULT

• Krasner DL. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage. 2002 May;48(5):38-43.

  PMID: 12046489 RESULT

• Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.

  PMID: 9188971 RESULT

• Haque G, Haweizy R, Bashaireh K, Malmstedt J, Alga A. Impact of injury mechanism on early wound closure in patients with acute conflict-related extremity wounds: A prospective cohort analysis from two civilian hospitals in Iraq and Jordan. World J Surg. 2024 Aug;48(8):1822-1828. doi: 10.1002/wjs.12276. Epub 2024 Jul 5.

  PMID: 38970237 DERIVED

• Alga A, Lofgren J, Haweizy R, Bashaireh K, Wong S, Forsberg BC, von Schreeb J, Malmstedt J. Cost analysis of negative-pressure wound therapy versus standard treatment of acute conflict-related extremity wounds within a randomized controlled trial. World J Emerg Surg. 2022 Feb 10;17(1):9. doi: 10.1186/s13017-022-00415-1.

  PMID: 35144650 DERIVED

• Alga A, Haweizy R, Bashaireh K, Wong S, Lundgren KC, von Schreeb J, Malmstedt J. Negative pressure wound therapy versus standard treatment in patients with acute conflict-related extremity wounds: a pragmatic, multisite, randomised controlled trial. Lancet Glob Health. 2020 Mar;8(3):e423-e429. doi: 10.1016/S2214-109X(19)30547-9.

  PMID: 32087175 DERIVED

• Alga A, Wong S, Haweizy R, Conneryd Lundgren K, von Schreeb J, Malmstedt J. Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 26;7(11):e12334. doi: 10.2196/12334.

  PMID: 30478024 DERIVED

MeSH Terms

Conditions

Wounds, Gunshot; Arm Injuries; Leg Injuries; Wound Infection; Wounds and Injuries; Blast Injuries

Condition Hierarchy (Ancestors)

Wounds, Penetrating; Infections; Barotrauma

Study Officials

• Jonas Malmstedt, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 14, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

JO (1); IR (1)