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Open Access Study protocol

The effect of triclosan coated sutures on rate of Surgical Site Infection after hip and knee replacement: a protocol for a double-blind randomised controlled trial

Andrew P Sprowson1*, Cyrus D Jensen2, Nick Parsons1, Paul Partington2, Kevin Emmerson2, Ian Carluke2, Seif Asaad2, Roland Pratt2, Scott Muller2 and Mike R Reed2

Author Affiliations

1 Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK

2 Northumbria NHS Foundation Trust, Rake Lane, North Shields, Tyne and Wear, UK

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BMC Musculoskeletal Disorders 2014, 15:237  doi:10.1186/1471-2474-15-237

Published: 14 July 2014

Abstract

Background

187,000 hip and knee joint replacements are performed every year in the National Health Service (NHS). One of the commonest complications is surgical site infection (SSI), and this represents a significant burden in terms of patient morbidity, mortality and cost to health services around the world. The aim of this randomised controlled trial (RCT) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement (TKR) and total hip replacement (THR).

Methods

2400 patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT. Participants are recruited before surgery and randomised to either standard care or intervention group. Participants, outcome assessors and statistician are blind to treatment allocation throughout the study. The intervention consists of triclosan coated sutures vs. standard non-coated sutures. The primary outcome is the Health protection Agency (HPA) defined superficial surgical site infection at 30 days. Secondary outcomes include HPA defined deep surgical site infection at 12 months, length of hospital stay, critical care stay, and payer costs.

Discussion

To date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention, particularly those that can be translated across the surgical specialities. The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement. If triclosan coated sutures are found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement.

Trial registration

Current Controlled Trials ISRCTN 17807356.