Wound Infection Clinical Trial
— VACoCREWOfficial title:
A Prospective, Randomized, Controlled Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds (VACoCREW Trial)
NCT number | NCT02444598 |
Other study ID # | KISOS001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | January 2019 |
Verified date | March 2019 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | January 2019 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Wounds presenting >72 hours following initial trauma. - Wounds that are considered ready for primary closure by suture or split-thickness skin graft. |
Country | Name | City | State |
---|---|---|---|
Iraq | Emergency Hospital | Erbil | Kurdistan Region |
Jordan | Ar Ramtha Hospital | Ar Ramtha |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Center for Molecular Medicine, Jordan University of Science and Technology, Medecins Sans Frontieres, Netherlands, Stockholm South General Hospital |
Iraq, Jordan,
Aboutanos MB, Baker SP. Wartime civilian injuries: epidemiology and intervention strategies. J Trauma. 1997 Oct;43(4):719-26. Review. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Krasner DL. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage. 2002 May;48(5):38-43. Review. — View Citation
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, Martínez JM, Grudzien G, Ichioka S, Ingemansson R, Malmsjo M, Rome P, Vig S, Runkel N, Martin R, Smith — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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, Bala — View Citation
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. Review. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2015;6: — View Citation
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. Review. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Early wound closure | Wound closure, either by suture or split-thickness skin graft | Day five +-1 | |
Primary | 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 | Rate of wound healing | Days to wound closure by suture or split-thickness skin graft | Days (between 1 and 50) | |
Secondary | Wound infection | Verified by either positive culture or clinical sign of infection, defined as purulent discharge | Days (between 1 and 50) | |
Secondary | Time until wound is deemed no longer requiring professional care | Days (between 1 and 50) | ||
Secondary | Time to discharge | Number of days to discharge | Days (between 1 and 50) | |
Secondary | Quality of life aspects | Quality of life aspects including noise generated by the NPWT pump, movement impairment, skin irritation, odour, sleep quality, discomfort during dressing changes and pain | Days five and eight | |
Secondary | Full wound healing at follow-up | Full epithelialization | Day 30 following wound closure | |
Secondary | Septicaemia | Septicaemia verified by positive blood culture | Days (between 1 and 50) | |
Secondary | Mortality | Death | Days (between 1 and 50) | |
Secondary | Wound size ratio day fourteen | Wound size day fourteen divided by size day zero, i.e. wound healing rate after fourteen days | Day 14 | |
Secondary | Number of surgeries | Days (between 1 and 50) |
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