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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 TraumaThe WHIST Randomized Clinical Trial

Educational Objective
To learn about incisional negative pressure wound therapy for traumatic fracture injuries.
1 Credit CME
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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Article Information

Corresponding Author: Matthew L. Costa, PhD, University of Oxford, Oxford OX3 9DU, England (matthew.costa@ndorms.ox.ac.uk).

Accepted for Publication: January 5, 2020.

Author Contributions: Dr Costa and Ms Dutton had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Costa, Achten, Bruce, Dutton, Madan, Dritsaki, Parsons, Fernandez, Grant, Nanchahal.

Acquisition, analysis, or interpretation of data: Costa, Achten, Knight, Bruce, Dritsaki, Grant, Nanchahal.

Drafting of the manuscript: Costa, Achten, Bruce, Dutton, Dritsaki, Fernandez, Grant.

Critical revision of the manuscript for important intellectual content: Achten, Knight, Dutton, Madan, Dritsaki, Parsons, Nanchahal.

Statistical analysis: Knight, Dutton.

Obtained funding: Costa, Achten, Dutton, Madan, Parsons, Fernandez, Nanchahal.

Administrative, technical, or material support: Costa, Achten, Bruce, Dutton.

Supervision: Costa, Dutton, Madan, Grant.

Conflict of Interest Disclosures: Dr Bruce reported receiving personal fees from Medtronic. Dr Nanchahal reported receiving personal fees and nonfinancial support from Smith & Nephew and Orthofix. No other disclosures were reported.

Funding/Support: This project was funded by grant HTA14/199/14 from the UK National Institute for Health Research Health Technology Assessment Programme and was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Smith and Nephew provided incisional negative pressure wound therapy dressings (PICO single use negative pressure wound therapy system) to recruiting centers.

Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

WHIST Trial Collaborators: Peter Hull, MBChB (Cambridge University Hospitals NHS Foundation Trust), Simon Scott, MBChB (Aintree University Hospital), David Melling, MBChB (Royal National Orthopaedic Hospital NHS Trust), Javed Salim, MBBS (Hull University Teaching Hospitals NHS Trust), Hemant Sharma, MS (Hull University Teaching Hospitals NHS Trust), William Eardley, MD (South Tees Hospitals NHS Foundation Trust), Peter Giannoudis, MD (University of Leeds), Jitendra Mangwani, MBBS (University Hospitals of Leicester NHS Trust), Andrew Riddick, MBBCh (North Bristol NHS Trust), Paul Harnett, MBChB (King’s College Hospital NHS Foundation Trust), Edward Mills, MBBS (Sheffield Teaching Hospitals NHS Foundation Trust), Mike Reed, PhD (Northumbria Healthcare NHS Foundation Trust), Ben Ollivere, MD (University of Nottingham), Xavier Griffin, PhD (University of Oxford), Mark Brinsden, MBBS (Plymouth Hospitals NHS Trust), Ravichandran Karthikeyan, MBBS (University Hospitals Birmingham NHS Foundation Trust), Peter Bates, MSBS (Barts Health NHS Trust), Benedict Rogers, PhD (Brighton and Sussex University Hospitals NHS Trust), Haroon Majeed, MBBS (University Hospitals of North Midlands NHS Trust), Damian McClelland, MBBS (University Hospitals of North Midlands NHS Trust), Sharad Bhatnagar, MS (Newcastle upon Tyne Hospitals NHS Foundation Trust), Caroline Hing, PhD (St Georges University Hospitals NHS Foundation Trust), Rajarshi Bhattacharya, MBBS (Imperial College Healthcare NHS Trust), Usman Butt, MBChB (Salford Royal NHS Foundation Trust), George Cox, MD (University Hospital Southampton NHS Foundation Trust), Khitish Mohanty, MBBS (Cardiff and Vale University LHB), Mateen Arastu, MBBS (University Hospitals Coventry and Warwickshire NHS Trust), Paul Harwood, MBChB (Leeds Teaching Hospitals NHS Trust), Alex Sims, PhD (South Tees Hospitals NHS Foundation Trust), Brett Rocos, MD (North Bristol NHS Trust), Ian Baxter, MBBS (Sheffield Teaching Hospitals NHS Foundation Trust), Tanvir Khan, MBBS (University of Nottingham), Paul Guyuer, MBBS (Plymouth Hospitals NHS Trust), Siddhant Kapoor, MBBS (University Hospitals Birmingham NHS Foundation Trust), Michalis Kaminaris, MBBS (St Georges University Hospitals NHS Foundation Trust), Edward Massa, MBBS (King’s College Hospital NHS Foundation Trust), Richard Unsworth, MBBS (Salford Royal NHS Foundation Trust), Robert Jordan, MBChB (University Hospitals Coventry and Warwickshire NHS Trust), Tarek Boutefnouchet, MBChB (University Hospitals Coventry and Warwickshire NHS Trust), Laura Beddard, MBBS (Poole Hospital NHS Foundation Trust), and Graham Lawton, MD (Imperial College Healthcare NHS Trust).

Disclaimer: The views expressed are those of the authors and not necessarily those of the UK National Health Service, the National Institute for Health Research, or the Department of Health.

Data Sharing Statement: See Supplement 4.

Additional Contributions: We thank all those involved in the WHIST Trial, including the patients and the research associates at all the research sites and in particular Louise Spoors (University of Oxford), Marta Campolier, PhD (University of Oxford), and Damian Haywood (University of Oxford) for their input in trial coordination and management, Suzanne Jones for input as a lay representative, James Masters, PhD (University of Oxford), for help with the analysis of clinical data, and Karan Vadher, MSc (University of Oxford), for help with the statistical analysis. Louise Spoors, Marta Campolier, Damian Haywood, and Karan Vadher were partially funded by the National Institute for Health Research award. The others listed did not receive funding for their contributions.

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