Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy.
Lower extremity trauma
Negative pressure wound therapy
Randomised controlled trial
Statistical analysis plan
Surgical site infection
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
28 Mar 2019
28 Mar 2019
Historique:
received:
10
08
2018
accepted:
08
03
2019
entrez:
30
3
2019
pubmed:
30
3
2019
medline:
4
9
2019
Statut:
epublish
Résumé
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. 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. 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. International Standard Randomised Controlled Trials database, ISRCTN12702354 . Registered on 9 December 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
International Standard Randomised Controlled Trials database, ISRCTN12702354 . Registered on 9 December 2015.
Identifiants
pubmed: 30922364
doi: 10.1186/s13063-019-3282-y
pii: 10.1186/s13063-019-3282-y
pmc: PMC6438006
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
186Subventions
Organisme : Department of Health
ID : HTA/14/199/14
Pays : United Kingdom
Organisme : Health Technology Assessment Programme
ID : 14/199/14
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