Abstract
BackgroundIn the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. One of the factors which may reduce the risk of surgical site infection is the type of dressing applied over the closed incision. The WHIST trial evaluates the effects of negative-pressure wound therapy (NPWT) compared with standard dressings.Methods/designThe WHIST trial is a multicentre, parallel group, randomised controlled trial. The primary outcome is the rate of deep surgical site infection at 30 days after major trauma. Secondary outcomes are measured at 3 and 6 months post-randomisation and include the Disability Rating Index, the EuroQoL EQ-5D-5 L, the Doleur Neuropathique Questionnaire, a patient-reported scar assessment, and record of complications. The analysis approaches for the primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The full WHIST protocol has already been published.DiscussionThis paper provides details of the planned statistical analyses for this trial and will reduce the risks of outcome reporting bias and data driven results.Trial registrationInternational Standard Randomised Controlled Trials database, ISRCTN12702354. Registered on 9 December 2015.
Highlights
In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high
The surgical incision is covered with an adhesive dressing or gauze maintained in place with a bandage to protect the wound from contamination from
The protocol paper for the Wound Healing In Surgery for major Trauma (WHIST) trial has been published previously [14]; the aim of this paper is to report in detail the analysis plan as agreed by the trial steering committee in March 2018
Summary
In the context of major trauma, the rate of wound infection in surgical incisions created during fracture fixation amongst patients with closed high-energy injuries is high. The WHIST trial evaluates the effects of negative-pressure wound therapy (NPWT) compared with standard dressings. One of the factors which may reduce the risk of surgical site infection in the surgical wounds of major trauma patients is the type of dressing applied over the closed incision at the completion of the operative procedure. Negative-pressure wound therapy (NPWT) is an alternative form of dressing which may be applied to closed surgical incisions. In this treatment, an open-cell, solid foam overlies the incision and is covered with a semipermeable membrane. A sealed tube is used to connect the foam to a pump which creates a partial vacuum over the wound
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