Costa ML, et al. - Multicenter randomized trial performed in the UK Major Trauma Network in order to evaluate the disability, rate of deep infection, and quality of life in subjects 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. Researchers reported that use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months among subjects with a severe open fracture of the lower limb. This treatment was not recommended for severe open fractures.

Methods

• From July 2012 through December 2015, 460 subjects aged 16 years or older with a severe open fracture of the lower limb were enrolled.
• After that, final outcome data were gathered through November 2016.
• Presentation more than 72 hours after injury and inability to complete questionnaires were the exclusion criteria.
• They analyzed 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).
• The primary outcome measure was Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months, with a minimal clinically important difference of 8 points.
• 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 were the secondary outcomes.

Results

• The study findings suggested that among 460 subjects who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial.
• No statistically significant differences were found 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]).