Protocol > Research Protocol
Alga A, Bashaireh K, Wong S, Lundgren KC, von Schreeb J
1 July 2018
Extremity wounds and fractures constitute the majority of conflict-related traumatic injuries, both for civilians (1) and combatants (2). Conflict-related injuries often result in soft and boney tissue being contaminated with foreign material, generally leading to secondary infection (3,4). 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. Due to a plastic film overlaying the wound the risk of wound contamination is reduced. 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 (5). The technique has previously been used in the treatment of acute conflict-related wounds with satisfactory results (6–8).
Cochrane reviews of NPWT for the treatment of chronic wounds (9) and surgical wounds (10) 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 (11). For the use in limb trauma, NPWT is considered suitable for complex soft tissue injuries (12). NPWT appears to be an effective and safe adjunctive treatment of high-energy combat wounds but existing results are retrospective and lack follow-up (13). 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 (14) and bleeding, predominantly minor bleeding from granulation tissue (15). 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.
Cochrane reviews of NPWT for the treatment of chronic wounds (9) and surgical wounds (10) 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 (11). For the use in limb trauma, NPWT is considered suitable for complex soft tissue injuries (12). NPWT appears to be an effective and safe adjunctive treatment of high-energy combat wounds but existing results are retrospective and lack follow-up (13). 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 (14) and bleeding, predominantly minor bleeding from granulation tissue (15). 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.
Journal Article > ResearchFull Text
Lancet Global Health. 1 March 2020; Volume 8 (Issue 3); DOI:10.1016/S2214-109X(19)30547-9
Älgå ABK, Haweizy R, Bashaireh K, Wong S, Lundgren KC, et al.
Lancet Global Health. 1 March 2020; Volume 8 (Issue 3); DOI:10.1016/S2214-109X(19)30547-9
Background: In armed conflict, injuries among civilians are usually complex and commonly affect the extremities. Negative pressure wound therapy (NPWT) is an alternative to standard treatment of acute conflict-related extremity wounds. We aimed to compare the safety and effectiveness of NPWT with that of standard treatment.
Methods: In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual.
Findings: Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI -5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI -12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups.
Interpretation: NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence.
Funding: The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.
Methods: In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual.
Findings: Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI -5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI -12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups.
Interpretation: NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence.
Funding: The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.
Journal Article > ResearchFull Text
World J Emerg Surg. 10 February 2022; Volume 17 (Issue 1); 9.; DOI:10.1186/s13017-022-00415-1
Alga A, Lofgren J, Haweizy R, Bashaireh K, Wong S, et al.
World J Emerg Surg. 10 February 2022; Volume 17 (Issue 1); 9.; DOI:10.1186/s13017-022-00415-1
BACKGROUND
Clinical outcomes after negative-pressure wound therapy (NPWT) and standard treatment of conflict-related extremity wounds are similar. In resource-limited settings, cost affects the choice of treatment. We aimed to estimate treatment-related costs of NPWT in comparison with standard treatment for conflict-related extremity wounds.
METHODS
We derived outcome data from a randomized, controlled superiority trial that enrolled adult (≥ 18 years) patients with acute (≤ 72 h) conflict-related extremity wounds at two civilian hospitals in Jordan and Iraq. Primary endpoint was mean treatment-related healthcare costs (adjusted to 2019 US dollars).
RESULTS
Patients were enrolled from June 9, 2015, to October 24, 2018. A total of 165 patients (155 men [93.9%]; 10 women [6.1%]; and median [IQR] age, 28 [21-34] years) were included in the analysis. The cost per patient treated with NPWT was $142 above that of standard treatment. Overall, results were robust in a sensitivity analysis.
CONCLUSIONS
With similar clinical outcomes compared to standard care, our results do not support the use of NPWT in routine treatment of conflict-related extremity wounds at civilian hospitals in resource scarce settings. Trial registration NCT02444598.
Clinical outcomes after negative-pressure wound therapy (NPWT) and standard treatment of conflict-related extremity wounds are similar. In resource-limited settings, cost affects the choice of treatment. We aimed to estimate treatment-related costs of NPWT in comparison with standard treatment for conflict-related extremity wounds.
METHODS
We derived outcome data from a randomized, controlled superiority trial that enrolled adult (≥ 18 years) patients with acute (≤ 72 h) conflict-related extremity wounds at two civilian hospitals in Jordan and Iraq. Primary endpoint was mean treatment-related healthcare costs (adjusted to 2019 US dollars).
RESULTS
Patients were enrolled from June 9, 2015, to October 24, 2018. A total of 165 patients (155 men [93.9%]; 10 women [6.1%]; and median [IQR] age, 28 [21-34] years) were included in the analysis. The cost per patient treated with NPWT was $142 above that of standard treatment. Overall, results were robust in a sensitivity analysis.
CONCLUSIONS
With similar clinical outcomes compared to standard care, our results do not support the use of NPWT in routine treatment of conflict-related extremity wounds at civilian hospitals in resource scarce settings. Trial registration NCT02444598.