Wounds, GunshotVACoCREWNCT02444598
Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds
A study testing Vaccum Assisted Closure device and Conventional wound dressings in people with Wounds, Gunshot and Arm Injuries, run by Karolinska Institutet at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds, Gunshot, Arm Injuries, Leg Injuries
- What is being tested?
- Vaccum Assisted Closure device and Conventional wound dressings
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Wounds presenting >72 hours following initial trauma.
- Wounds that are considered ready for primary closure by suture or split-thickness skin graft.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the detailed description
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.
- Conditions
- Wounds, Gunshot, Arm Injuries, Leg Injuries, Wound Infection
- Being tested
- Vaccum Assisted Closure device, Conventional wound dressings
- Keywords
- wounds, negative-pressure wound therapy, conflict, gunshot wound, blast injuries, civilian, war
- Medical subject headings
- Wounds, Gunshot, Arm Injuries, Leg Injuries, Wound Infection, Wounds and Injuries, Blast Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccum Assisted Closure deviceDevice
Negative-pressure wound therapy
Conventional wound dressingsProcedure or surgery
Conventional wound dressings
| Study group | Role | What they receive |
|---|---|---|
| Negative-pressure wound therapy | Experimental | Vaccum Assisted Closure device. Patients will receive negative-pressure wound therapy according to manufacturer treatment guidelines. Receives: Device: Vaccum Assisted Closure device |
| Standard | Active comparator | Patients will be treated with conventional wound dressings according to local treatment protocols. Receives: Procedure: Conventional wound dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early wound closure
Wound closure, either by suture or split-thickness skin graft
Measured: 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.
Measured: Days (between 1 and 50)
Secondary outcomes (10)
Rate of wound healing
Days to wound closure by suture or split-thickness skin graft
Measured: Days (between 1 and 50)
Wound infection
Verified by either positive culture or clinical sign of infection, defined as purulent discharge
Measured: Days (between 1 and 50)
Time until wound is deemed no longer requiring professional care
Measured: Days (between 1 and 50)
Time to discharge
Number of days to discharge
Measured: Days (between 1 and 50)
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
Measured: Days five and eight
Full wound healing at follow-up
Full epithelialization
Measured: Day 30 following wound closure
Septicaemia
Septicaemia verified by positive blood culture
Measured: Days (between 1 and 50)
Mortality
Death
Measured: Days (between 1 and 50)
Wound size ratio day fourteen
Wound size day fourteen divided by size day zero, i.e. wound healing rate after fourteen days
Measured: Day 14
Number of surgeries
Measured: Days (between 1 and 50)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Wounds, GunshotStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, Jordan University of Science and Technology, Stockholm South General Hospital, Center for Molecular Medicine
- Responsible party
- Principal investigator, Jonas Malmstedt, Karolinska Institutet
- Investigators
- Jonas Malmstedt, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444598
- Sponsor's protocol ID
- KISOS001
- Acronym
- VACoCREW
- Status last verified
- Mar 2019
- First submitted
- 12 May 2015
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9356079Owens 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.
PubMed 17414553Fares 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.
PubMed 23999350Covey 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.
PubMed 10898201Krug 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.
PubMed 21316515Machen 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.
PubMed 20084702Peck 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.
PubMed 17543685Leininger 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.
PubMed 17099530Ubbink 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.
PubMed 18646080Webster 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.
PubMed 25287701Peinemann 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.
PubMed 21712971Bovill 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.
PubMed 18808432Hinck 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.
PubMed 20358706Krasner DL. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage. 2002 May;48(5):38-43.
PubMed 12046489Argenta 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.
PubMed 9188971
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial of Negative-pressure Wound Therapy Use in Conflict-related Extremity Wounds (VACoCREW Trial)
- ClinicalTrials.gov ID
- NCT02444598
- Acronym / sponsor ID
- VACoCREW / KISOS001
- Conditions
- Wounds, Gunshot, Arm Injuries, Leg Injuries, Wound Infection
- Keywords
- wounds, negative-pressure wound therapy, conflict, gunshot wound, blast injuries, civilian, war
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, Jordan University of Science and Technology, Stockholm South General Hospital, Center for Molecular Medicine
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative-pressure wound therapy | Experimental | Device: Vaccum Assisted Closure deviceVaccum Assisted Closure device. Patients will receive negative-pressure wound therapy according to manufacturer treatment guidelines. |
| Standard | Active comparator | Procedure: Conventional wound dressingsPatients will be treated with conventional wound dressings according to local treatment protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Wounds presenting >72 hours following initial trauma.
- Wounds that are considered ready for primary closure by suture or split-thickness skin graft.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccum Assisted Closure deviceNegative-pressure wound therapy | Device | Negative-pressure wound therapy |
| Conventional wound dressingsConventional wound dressings | Procedure or surgery | Standard |
Primary outcome
Early wound closure
Time frame: Day five +-1
Wound closure, either by suture or split-thickness skin graft
Cost-effectiveness comparing outcomes from NPWT and standard treatment
Time frame: Days (between 1 and 50)
Costs from the health care provider's perspective will be used. Cost-effectiveness will be expressed in US dollars.
10 secondary outcomes
Rate of wound healing
Time frame: Days (between 1 and 50)
Wound infection
Time frame: Days (between 1 and 50)
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)
Quality of life aspects
Time frame: Days five and eight
Full wound healing at follow-up
Time frame: Day 30 following wound closure
Septicaemia
Time frame: Days (between 1 and 50)
Mortality
Time frame: Days (between 1 and 50)
Wound size ratio day fourteen
Time frame: Day 14
Number of surgeries
Time frame: Days (between 1 and 50)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Results publication: PubMed 9356079Aboutanos MB, Baker SP. Wartime civilian injuries: epidemiology and intervention strategies. J Trauma. 1997 Oct;43(4):719-26. doi: 10.1097/00005373-199710000-00031.
- Results publication: PubMed 17414553Owens 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.
- Results publication: PubMed 23999350Fares 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.
- Results publication: PubMed 10898201Covey 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.
- Results publication: PubMed 21316515Krug 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.
- Results publication: PubMed 20084702Machen 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.
- Results publication: PubMed 17543685Peck 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.
- Results publication: PubMed 17099530Leininger 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.
- Results publication: PubMed 18646080Ubbink 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.
- Results publication: PubMed 25287701Webster 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.
- Results publication: PubMed 21712971Peinemann 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.
- Results publication: PubMed 18808432Bovill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Malmstedt, MD, PhD principal investigator
Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccum Assisted Closure device and Conventional wound dressings in people with Wounds, Gunshot and Arm Injuries, run by Karolinska Institutet at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq, Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early wound closure (time frame: Day five +-1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02444598, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.