Negative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT

• DOI: 10.3310/hta22730
• Publication Date: 2018-12-21T09:57:45Z
• Authors: Matthew L Costa; Juul Achten; Julie Bruce; Sonia Davis; Susie Hennings; Keith Willett; Stavros Petrou; Steven Jeffery; Damian Griffin; Ben Parker; James Masters; Sarah E Lamb; Elizabeth Tutton; Nick Parsons
• Keywords: Negative-pressure wound therapy; Open fracture; Debridement (dental)

Background Open fractures of the lower limb occur when a broken bone penetrates skin and is exposed to outside environment. These are life-changing injuries. The risk deep infection may be as high 27%. type dressing applied after surgical debridement could potentially reduce in open-fracture wound. Objectives To assess disability, rate infection, quality life resource use patients with severe open fracture treated negative-pressure wound therapy (NPWT) versus standard management first Design A pragmatic, multicentre randomised controlled trial. Setting Twenty-four specialist trauma hospitals UK Major Trauma Network. Participants total 460 aged ≥ 16 years were recruited from July 2012 through December 2015. Patients excluded if they presented more than 72 hours their injury or unable complete questionnaires. Interventions Negative-pressure ( n = 226) where an ‘open-cell’ solid foam gauze was placed over surface connected suction pump which created partial vacuum dressings not involving negative pressure 234). Main outcome measures Disability Rating Index (DRI) – score 0 (no disability) 100 (completely disabled) at 12 months primary measure, minimal clinically important difference 8 points. secondary outcomes collected 3, 6, 9 post randomisaton. Results There no evidence patients’ DRI months. mean NPWT group 45.5 points [standard deviation (SD) 28.0 points] 42.4 (SD 24.2 points) group, giving –3.9 (95% confidence interval –8.9 1.2 favour p 0.132). HRQoL number site infections other complications any point surgery. did cost treatment it associated low probability cost-effectiveness. Limitations Owing emergency nature interventions, we anticipated that some who into trial would subsequently unwilling take part. Such post-randomisation withdrawal have posed external validity However, great majority these (85%) found ineligible randomisation. Therefore, can confident took part representative population limb. Conclusions Contrary existing literature current clinical guidelines, do provide economic benefit for Future work should investigate alternative strategies incidence improve Two specific areas (1) topical antibiotic preparations (2) role orthopaedic implants antimicrobial coatings fixing fracture. Trial registration Current Controlled Trials ISRCTN33756652 UKCRN Portfolio ID 11783. Funding This project funded by National Institute Health Research (NIHR) Technology Assessment programme will published full ; Vol. 22, No. 73. See NIHR Journals Library website further information.