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Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture : the WOLLF RCT
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Costa, Matthew L., Achten, Juul, Bruce, J. (Julie), Davis, Sonia, Hennings, Susie, Willett, Keith, Petrou, Stavros, Jeffery, Steven, Griffin, Damian R., Parker, Benjamin A., Masters, James P. M., Lamb, S. E. (Sallie E.), Tutton, Elizabeth and Parsons, Nicholas R. (2018) Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture : the WOLLF RCT. Health Technology Assessment, 22 (73). pp. 1-162. doi:10.3310/hta22730 ISSN 1366-5278.
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Official URL: http://dx.doi.org/10.3310/hta22730
Abstract
Background
Open fractures of the lower limb occur when a broken bone penetrates the skin and is exposed to the outside environment. These are life-changing injuries. The risk of deep infection may be as high as 27%. The type of dressing applied after surgical debridement could potentially reduce the risk of infection in the open-fracture wound.
Objectives
To assess the disability, rate of deep infection, quality of life and resource use in patients with severe open fracture of the lower limb treated with negative-pressure wound therapy (NPWT) versus standard wound management after the first surgical debridement of the wound.
Design
A pragmatic, multicentre randomised controlled trial.
Setting
Twenty-four specialist trauma hospitals in the UK Major Trauma Network.
Participants
A total of 460 patients aged ≥ 16 years with a severe open fracture of the lower limb were recruited from July 2012 through to December 2015. Patients were excluded if they presented more than 72 hours after their injury or were unable to complete questionnaires.
Interventions
Negative-pressure wound therapy (n = 226) where an ‘open-cell’ solid foam or gauze was placed over the surface of the wound and connected to a suction pump which created a partial vacuum over the dressing versus standard dressings not involving negative pressure (n = 234).
Main outcome measures
Disability Rating Index (DRI) – a score of 0 (no disability) to 100 (completely disabled) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. The secondary outcomes were deep infection, quality of life and resource use collected at 3, 6, 9 and 12 months post randomisaton.
Results
There was no evidence of a difference in the patients’ DRI at 12 months. The mean DRI in the NPWT group was 45.5 points [standard deviation (SD) 28.0 points] versus 42.4 points (SD 24.2 points) in the standard dressing group, giving a difference of –3.9 points (95% confidence interval –8.9 to 1.2 points) in favour of standard dressings (p = 0.132). There was no difference in HRQoL and no difference in the number of surgical site infections or other complications at any point in the 12 months after surgery. NPWT did not reduce the cost of treatment and it was associated with a low probability of cost-effectiveness.
Limitations
Owing to the emergency nature of the interventions, we anticipated that some patients who were randomised into the trial would subsequently be unable or unwilling to take part. Such post-randomisation withdrawal of patients could have posed a risk to the external validity of the trial. However, the great majority of these patients (85%) were found to be ineligible after randomisation. Therefore, we can be confident that the patients who took part were representative of the population with severe open fractures of the lower limb.
Conclusions
Contrary to the existing literature and current clinical guidelines, NPWT dressings do not provide a clinical or an economic benefit for patients with an open fracture of the lower limb.
Future work
Future work should investigate alternative strategies to reduce the incidence of infection and improve outcomes for patients with an open fracture of the lower limb. Two specific areas of potentially great benefit are (1) the use of topical antibiotic preparations in the open-fracture wound and (2) the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture.
Trial registration
Current Controlled Trials ISRCTN33756652 and UKCRN Portfolio ID 11783.
| Item Type: | Journal Article | ||||||
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| 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 |
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| Library of Congress Subject Headings (LCSH): | Leg -- Wounds and injuries -- Treatment, Leg -- Fractures, Bandages and bandaging, Surgical dressings | ||||||
| Journal or Publication Title: | Health Technology Assessment | ||||||
| Publisher: | NIHR Health Technology Assessment programme | ||||||
| ISSN: | 1366-5278 | ||||||
| Official Date: | December 2018 | ||||||
| Dates: |
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| Volume: | 22 | ||||||
| Number: | 73 | ||||||
| Page Range: | pp. 1-162 | ||||||
| DOI: | 10.3310/hta22730 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Reuse Statement (publisher, data, author rights): | © Queen’s Printer and Controller of HMSO 2018. This work was produced by Costa et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 28 January 2019 | ||||||
| Date of first compliant Open Access: | 29 January 2019 | ||||||
| RIOXX Funder/Project Grant: |
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