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Original Investigation
February 11, 2020

Effect of Incisional Negative Pressure Wound Therapy vs Standard Wound Dressing on Deep Surgical Site Infection After Surgery for Lower Limb Fractures Associated With Major Trauma: The WHIST Randomized Clinical Trial

Author Affiliations
  • 1Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England
  • 2Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, England
  • 3Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, England
  • 4Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, England
  • 5Nuneaton, England
JAMA. 2020;323(6):519-526. doi:10.1001/jama.2020.0059
Visual Abstract.
Visual Abstract.
Incisional Negative Pressure vs Standard Wound Dressing and Surgical Site Infection After Surgery for Lower Limb Fractures
Incisional Negative Pressure vs Standard Wound Dressing and Surgical Site Infection After Surgery for Lower Limb Fractures
Key Points

Question  Among patients undergoing surgery for lower limb fractures related to major trauma, is there a difference in deep surgical infection rates when the wound is treated with incisional negative pressure wound therapy vs standard wound dressing?

Findings  In this randomized clinical trial that included 1548 adults, there was no statistically significant difference in the rate of deep surgical site infection at 30 days between incisional negative pressure wound therapy (5.8%) and standard wound dressing (6.7%).

Meaning  The findings do not support the use of incisional negative pressure wound therapy for surgical wounds associated with lower limb fractures from major trauma, although the event rate at 30 days was lower than expected.

Abstract

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 (n = 785), which involved a specialized dressing used to create negative pressure over the wound, vs standard wound dressing not involving negative pressure (n = 763).

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 (mean [SD] age, 49.8 [20.3] years; 561 [36%] were aged ≤40 years; 583 [38%] women; and 881 [57%] had multiple injuries), 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 in 6.68% (50 of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57 to 1.33]; absolute risk difference, −0.77% [95% CI, −3.19% to 1.66%]; P = .52). There was no significant difference in the deep surgical site infection rate at 90 days (11.4% [72 of 629 patients] in the incisional negative pressure wound therapy group vs 13.2% [78 of 590 patients] in the standard wound dressing group; odds ratio, 0.84 [95% CI, 0.59 to 1.19]; absolute risk difference, −1.76% [95% CI, −5.41% to 1.90%]; P = .32). For the 5 prespecified secondary outcomes reported, there were no significant differences at any time point.

Conclusions and Relevance  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.

Trial Registration  isrctn.org Identifier: ISRCTN12702354

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