A new study published in JAMA has found no difference in disability, rate of deep infection and QoL with negative pressure wound therapy (NPWT) vs standard wound management in patients with severe open fracture of the lower limb.
The randomised clinical trial was conducted by the University of Warwick Clinical Trials Unit and the University of Oxford, across 24 hospitals of the UK Major Trauma Network. A total of 460 patients aged 16 years or older were recruited from July 2012 through December 2015. Participants were randomly assigned to receive NPWT (n=226) or standard dressings (n=234). Final outcome data were collected through November 2016.
12 months after treatment, there were no statistically significant differences in mean Disability Rating Index scores between the NPWT and standard dressings group (mean difference, −3.9; 95% CI, −8.9 to 1.2; P=.13). With NPWT, the rate of deep surgical site infections was 7.1% compared with 8.1% with standard dressings (difference, 1%; 95% CI, −4.2% to 6.3%; P=.64).
No significant QoL differences were observed using the EuroQol 5-dimensions questionnaire (difference, 0.02; 95% CI, −0.05 to 0.08), the Short Form-12 Physical Component Score (difference, 0.5; 95% CI, −3.1 to 4.1) and the Mental Health Component Score (difference, −0.4; 95% CI, −2.2 to 1.4).
Co-author, Professor Julie Bruce, said: “Before this study there was only one small randomised clinical trial comparing standard wound dressings with the devices which suggested negative-pressure wound therapy improved patient outcomes. However it was conducted at one trauma centre and included only 59 patients. Despite the lack of strong evidence, clinical guidelines around the world recommended the use of these devices for open fracture wounds. These guidelines will need updating.”
