Matthew L Costa 1, Juul Achten 1, Ruth Knight 2, Julie Bruce 3, Susan J Dutton 2, Jason Madan 3, Melina Dritsaki 2, Nick Parsons 4, Miguel Fernandez 1, Richard Grant 5, Jagdeep Nanchahal 1, WHIST Trial Collaborators
Main idea: Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.
Importance: Following surgery to treat major trauma-related fractures, deep wound infection rates are high. It is not known if negative pressure wound therapy can reduce infection rates in this setting.
Objective: To assess outcomes in patients who have incisions resulting from surgery for lower limb fractures related to major trauma and were treated with either incisional negative pressure wound therapy or standard wound dressing.
Design, setting, and participants: A randomized clinical trial conducted at 24 trauma hospitals representing the UK Major Trauma Network that included 1548 patients aged 16 years or older who underwent surgery for a lower limb fracture caused by major trauma from July 7, 2016, through April 17, 2018, with follow-up to December 11, 2018.
Interventions: Incisional negative pressure wound therapy, which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure.
Main outcomes and measures: The primary outcome measure was deep surgical site infection at 30 days diagnosed according to the criteria from the US Centers for Disease Control and Prevention. A preplanned secondary analysis of the primary outcome was performed at 90 days. The secondary outcomes were patient-reported disability (Disability Rating Index), health-related quality of life (EuroQol 5-level EQ-5D), surgical scar assessment (Patient and Observer Scar Assessment Scale), and chronic pain (Douleur Neuropathique Questionnaire) at 3 and 6 months, as well as other local wound healing complications at 30 days.
Results: Among 1548 participants who were randomized, 1519 (98%) had data available for the primary outcome. At 30 days, deep surgical site infection occurred in 5.84% (45 of 770 patients) of the incisional negative pressure wound therapy group and 6.68% of the standard wound dressing group. At 90 days, there was no significant difference in the deep surgical site infection rate. For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point. The study was published in the Journal of Neurosurgery.