Wound Infection Clinical Trial
Official title:
A Prospective, Randomized, Controlled Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds (VACoCREW Trial)
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.
Trial locations:
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.
Emergency hospital in Erbil, Iraq is a trauma hospital. Patients originate from armed
conflicts in Mosul and the Iraqi Kurdistan region.
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 wounds with
satisfactory results (Machen 2006; Peck et al. 2007; Leininger et al. 2006).
Cochrane reviews of NPWT for the treatment of chronic wounds (Ubbink et al. 2008) and
surgical wounds (Webster & Scuffham 2014) were inconclusive due to the lack of suitably
powered, high-quality trials. A recent systematic review of randomized, controlled trials
(RCTs) of NPWT for the treatment of acute and chronic wounds concluded there is a lack of
evidence and that good RCTs are needed (Peinemann & Sauerland 2011). For the use in limb
trauma, NPWT is considered suitable for complex soft tissue injuries (Bovill et al. 2008).
NPWT appears to be an effective and safe adjunctive treatment of high-energy combat wounds
but existing results are retrospective and lack follow-up (Hinck et al. 2010). The support of
RCTs is needed to establish best treatment strategies.
Summary of potential risks and benefits:
Both treatment methods (NPWT and conventional dressings) are well established and used in
Jordan for the treatment of acute and chronic wounds. As neither of the two treatment
modalities are known to be better in terms of outcome neither patient group may be regarded
as receiving preferential treatment. NPWT is generally considered a safe treatment method.
Potential benefits are shortened healing time and fewer infectious complications. Potential
risks are pain, mainly associated with dressing changes (Krasner 2002) and bleeding,
predominantly minor bleeding from granulation tissue (Argenta, Louis Morykwas 1997).
Conventional wound dressing has the potential benefit of being a safe treatment method used
for many years. Since this method permits air into the wound there is a potential risk of
contamination and the development of wound infection.
Objectives:
We aim to evaluate the efficacy and safety of NPWT in the treatment of traumatic extremity
wounds in a context associated with a high level of contamination and infection.
Design:
A prospective, randomized, controlled trial comparing NPWT to conventional dressing methods
in the treatment of conflict-related extremity wounds. Patients will continuously be included
as they present at the emergency department of the hospital in Ar Ramtha.
Information for patients and consent:
Written and oral information in English and Arabic will be given to eligible participants.
English versions of the participation information sheet and the consent form are provided as
appendices to this document. Participants will be informed regarding their right to withdraw
from the study and issues concerning confidentiality and the information sheet will remain
with the participant. No incentives or inducements will be provided to any participant.
Eligible concomitant therapies:
Any signs of infection will be treated according to local standard protocols. Wounds in need
of debridement will be debrided according to International Committee of the Red Cross (ICRC)
war surgery protocols.
Interventions:
Patients randomly assigned to NPWT will receive treatment according to manufacturer treatment
guidelines. Patients in the control group will be treated with conventional wound therapy
according to local treatment protocols. In both groups dressing changes will be performed
according to ICRC war surgery protocols.
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