Protocol Summary

A randomised controlled trial of standard care wound management versus negative pressure wound therapy in the treatment of adult patients with an open fracture of the lower limb.

 

Registrations

• ISRCTN33756652
• Ethical Approval 12/WM/0001
• UK CRN Portfolio 11783

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Trial Design

• Multicentre Randomised Controlled Trial
• 1:1 Randomisation
• Stratified by trial centre, and Gustilo and Anderson grade 2, 3, or 3 with vascular injury requiring surgical repair

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Inclusion Criteria

• Patient is aged 16 years or over
• Patient presents at hospital within 72 hours of injury
• Patient has an open fracture of the lower limb - graded as Gustilo and Anderson 2 or 3

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Exclusion Criteria

• Contra-indications to anaesthetic
• Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

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Primary Outcome

• To quantify and draw inferences on observed differences in the Disability Rating Index at 12 months after the open fracture

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Secondary Outcomes

• To quantify and draw inferences on patient reported differences in 'deep infection' of the limb, in the 12 months after the open fracture
• To quantify and draw inferences on observed differences in general quality of life (SF-12 and EQ-5D) in the 12 months after the open fracture
• To determine the number and nature of further surgical interventions related to the injury, during the first 12 months after the open fracture
• To investigate, using appropriate statistical and econmic analysis methods, the resource use, and thereby the cost effectiveness, of negative pressure wound therapy versus standard dressing for wounds associated with open fractures of the lower limb

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Target Recruitment

• The recruitment target of 460 consented patients was achieved on 10th December 2015. Well done everyone!

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Pilot centres

• University Hospital Coventry and Warwickshire, Mr Jonathan Young
• University Hospital Birmingham, Prof Sir Keith Porter
• John Radcliffe Hospital, Mr David Noyes
• The Royal Victoria Hospital, Mr Andrew Gray
• Frenchay Hospital, Mr Umraz Khan

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Funder

• NIHR HTA (10/57/20)

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Schedule

• Start date : 1st April 2012
• End date: 31st March 2017

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Chief Investigator

• Professor Matthew Costa

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Sponsors

• University of Warwick
• University Hospitals Coventry and Warwickshire NHS Trust