title: 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.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN 17807356.
authors.affiliation: Warwick Medical School, The University of Warwick, Coventry CV4 7AL, UK. a.p.sprowson@warwick.ac.uk.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Sprowson
authors.forename: Cyrus D
authors.initials: CD
authors.lastname: Jensen
authors.forename: Nick
authors.initials: N
authors.lastname: Parsons
authors.forename: Paul
authors.initials: P
authors.lastname: Partington
authors.forename: Kevin
authors.initials: K
authors.lastname: Emmerson
authors.forename: Ian
authors.initials: I
authors.lastname: Carluke
authors.forename: Seif
authors.initials: S
authors.lastname: Asaad
authors.forename: Roland
authors.initials: R
authors.lastname: Pratt
authors.forename: Scott
authors.initials: S
authors.lastname: Muller
authors.forename: Mike R
authors.initials: MR
authors.lastname: Reed
mesh_terms: D000891:Anti-Infective Agents, Local / Q000008:administration & dosage* / Q000191:economics; D019644:Arthroplasty, Replacement, Hip / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible / Q000191:economics; D004311:Double-Blind Method; D004739:England; D017048:Health Care Costs; D006801:Humans; D007902:Length of Stay; D012107:Research Design; D013530:Surgical Wound Infection / Q000191:economics / Q000209:etiology / Q000517:prevention & control*; D013536:Suture Techniques / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D013537:Sutures / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014260:Triclosan / Q000008:administration & dosage* / Q000191:economics
chemical_list: D000891:Anti-Infective Agents, Local; D020099:Coated Materials, Biocompatible; D014260:Triclosan