Abstract
Background187,000 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).Methods2400 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.DiscussionTo 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 registrationCurrent Controlled Trials ISRCTN 17807356.
Highlights
Total hip replacements (THR) and total knee replacements (TKR) are performed for relief of debilitating pain secondary to arthritis, and are the commonest forms of joint replacement performed in the UK
2030, the demand for primary total hip replacement is estimated to grow by 174% and the demand for primary total knee replacement is projected to grow by 673% [2] in the United States
The Northumbria Arthroplasty Suture Study (NASS) is an on-going two-centre double blind randomised controlled trial conducted at Northumbria National Health Service (NHS) Foundation Trust, one of the largest elective orthopaedic centres in the UK
Summary
The Northumbria Arthroplasty Suture Study (NASS) is an on-going two-centre double blind randomised controlled trial conducted at Northumbria NHS Foundation Trust, one of the largest elective orthopaedic centres in the UK. Risks No additional risks for study patients were expected, since all surgical procedures carried out within NASS represent clinically established standard methods of treatment in hip and knee replacement. Superficial incisional infection SSI that occurs within 30 days of surgery, involves only the skin or subcutaneous tissue of the incision & meets at least one of the following criteria: 1. Culture of organisms and pus cells present: fluid/tissue from superficial incision wound swab from superficial incision
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