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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds (VACoCREW Trial)

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.

Detailed Summary:

Trial location:

Médecins Sans Frontières/Doctors Without Borders (MSF) is one of the worlds leading independent organizations for medical humanitarian aid. MSF conducts an emergency trauma project in the Ministry of Health hospital in Ar Ramtha, Jordan, less than five kilometers from the border with Daraa governorate in Syria. A majority of patients within the project receive treatment for blast- and gunshot-related trauma wounds originating from the Syrian armed conflict. Within the project wound management has been difficult, often complicated by infection and antibiotic resistance. A need for wound therapy alternatives better than the conventional wound dressing method currently used has been identified.

Background:

Extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians (Aboutanos & Baker 1997) and combatants (Owens et al. 2007). Conflict-related injuries often result in soft and boney tissue being contaminated with foreign material, generally leading to secondary infection (Fares et al. 2013; Covey et al. 2000). Negative-pressure wound therapy (NPWT) is widely used in the treatment of wounds and is considered to promote wound healing and prevent infectious complications. The technique involves the application of a wound dressing through which a negative pressure is applied. Any wound and tissue fluid is drawn away from the area and collected into a canister. The risk of wound contamination is reduced by a plastic film overlaying the wound. NPWT is supported for use in a range of surgical applications, including after or in between debridements as a bridge to definite closure of soft tissue wounds (Krug et al. 2011). The technique has previously been used in the treatment of acute conflict-related wou
Sponsor: Karolinska Institutet

Current Primary Outcome: Early wound closure [ Time Frame: Day five +-1 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of wound healing [ Time Frame: Days (between 1 and 50) ]
    Days to wound closure by suture or split-thickness skin graft
  • Wound infection [ Time Frame: Days (between 1 and 50) ]
    Verified by either positive culture or clinical sign of infection, defined as purulent discharge
  • Time until wound is deemed no longer requiring professional care [ Time Frame: Days (between 1 and 50) ]
  • Time to discharge [ Time Frame: Days (between 1 and 50) ]
    Number of days to discharge
  • Quality of life aspects [ Time Frame: Days five and eight ]
    Quality of life aspects including noise generated by the NPWT pump, movement impairment, skin irritation, odour, sleep quality, discomfort during dressing changes and pain
  • Full wound healing at follow-up [ Time Frame: Day 30 following wound closure ]
    Full epithelialization
  • Septicaemia [ Time Frame: Days (between 1 and 50) ]
    Septicaemia verified by positive blood culture
  • Mortality [ Time Frame: Days (between 1 and 50) ]
    Death
  • Wound size ratio day fourteen [ Time Frame: Day 14 ]
    Wound size day fourteen divided by size day zero, i.e. wound healing rate after fourteen days
  • Cost of treatment method [ Time Frame: Days (between 1 and 50) ]


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: May 12, 2015
Date Started: June 2015
Date Completion: May 2018
Last Updated: May 9, 2017
Last Verified: May 2017