{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T18:31:56Z","timestamp":1792089116209,"version":"4.4.0"},"reference-count":64,"publisher":"National Institute for Health and Care Research","issue":"38","license":[{"start":{"date-parts":[[2020,8,1]],"date-time":"2020-08-01T00:00:00Z","timestamp":1596240000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["NIHR128966"],"award-info":[{"award-number":["NIHR128966"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>Major trauma is the leading cause of death in people aged &lt;\u200945 years. Patients with major trauma usually have lower-limb fractures. Surgery to fix the fractures is complicated and the risk of infection may be as high as 27%. The type of dressing applied after surgery could potentially reduce the risk of infection.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>To assess the deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use in patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with incisional negative-pressure wound therapy versus standard dressings.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>A pragmatic, multicentre, randomised controlled trial.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>Twenty-four specialist trauma hospitals representing the UK Major Trauma Network.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>A total of 1548 adult patients were randomised from September 2016 to April 2018. Exclusion criteria included presentation &gt;\u200972 hours after injury and inability to complete questionnaires.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Interventions<\/jats:title><jats:p>Incisional negative-pressure wound therapy (<jats:italic>n<\/jats:italic>\u2009=\u2009785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure (<jats:italic>n<\/jats:italic>\u2009=\u2009763). Trial participants and the treating surgeon could not be blinded to treatment allocation.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Main outcome measures<\/jats:title><jats:p>Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Results<\/jats:title><jats:p>A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50\/749) in the standard dressing group and 5.8% (45\/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33;<jats:italic>p<\/jats:italic>\u2009=\u20090.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;<jats:italic>p<\/jats:italic>\u2009=\u20090.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Limitations<\/jats:title><jats:p>Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-10\"><jats:title>Conclusions<\/jats:title><jats:p>The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-11\"><jats:title>Future work<\/jats:title><jats:p>Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-12\"><jats:title>Trial registration<\/jats:title><jats:p>Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-13\"><jats:title>Funding<\/jats:title><jats:p>This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in<jats:italic>Health Technology Assessment<\/jats:italic>; Vol. 24, No. 38. See the NIHR Journals Library for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta24380","type":"journal-article","created":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T13:04:03Z","timestamp":1598015043000},"page":"1-86","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT"],"prefix":"10.3310","volume":"24","clinical-trial-number":[{"clinical-trial-number":"isrctn12702354","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3644-1388","authenticated-orcid":true,"given":"Matthew L","family":"Costa","sequence":"first","affiliation":[{"name":"Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, 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