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Published in: Trials 1/2019

Open Access 01-12-2019 | Vacuum Therapy | Update

Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy

Authors: Ruth Knight, Louise M. Spoors, Matthew L. Costa, Susan J. Dutton

Published in: Trials | Issue 1/2019

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Abstract

Background

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. 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/design

The 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.

Discussion

This 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 registration

International Standard Randomised Controlled Trials database, ISRCTN12702354. Registered on 9 December 2015.
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Metadata
Title
Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy
Authors
Ruth Knight
Louise M. Spoors
Matthew L. Costa
Susan J. Dutton
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3282-y

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