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Effect of negative pressure wound therapy vs standard wound management on 12-month disability among adults with severe open fracture of the lower limb : the WOLLF randomised clinical trial

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UK WOLLF Collaboration (Including: Costa, Matthew L., Achten, Juul, Bruce, J. (Julie), Tutton, Elizabeth, Petrou, Stavros, Lamb, S. E. (Sallie E.) and Parsons, Nicholas R.). (2018) Effect of negative pressure wound therapy vs standard wound management on 12-month disability among adults with severe open fracture of the lower limb : the WOLLF randomised clinical trial. JAMA: The Journal of the American Medical Association, 319 (22). pp. 2280-2288. doi:10.1001/jama.2018.6452 ISSN 1538-3598.

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Official URL: https://doi.org/10.1001/jama.2018.6452

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Abstract

Importance

Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing.

Objectives

To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound.

Design, Setting, and Participants

Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires.

Interventions

NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n = 234).

Main Outcomes and Measures

Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to −0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months.

Results

Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients’ Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, −3.9 [95% CI, −8.9 to 1.2]; P = .13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95% CI, −4.2% to 6.3%]; P = .64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, −0.05 to 0.08]; Short Form–12 Physical Component Score, 0.5 [95% CI, −3.1 to 4.1] and Mental Health Component Score, −0.4 [95% CI, −2.2 to 1.4]).

Conclusions and Relevance

Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures.

Trial Registration isrctn.org Identifier: ISRCTN33756652

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Leg -- Fractures -- Treatment, Leg -- Wounds and injuries, Surgical dressings
Journal or Publication Title: JAMA: The Journal of the American Medical Association
Publisher: American Medical Association
ISSN: 1538-3598
Official Date: 12 June 2018
Dates:
DateEvent
12 June 2018Published
25 April 2018Modified
24 March 2018Accepted
Volume: 319
Number: 22
Page Range: pp. 2280-2288
DOI: 10.1001/jama.2018.6452
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Date of first compliant deposit: 26 April 2018
Date of first compliant Open Access: 12 December 2018
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
10/57/20Health Technology Assessment programmehttp://dx.doi.org/10.13039/501100000664
UNSPECIFIED[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
Version or Related Resource: http://wrap.warwick.ac.uk/104735
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