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

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.

The effect of triclosan-coated sutures on the rate of surgical site infection after hip and knee arthroplasty: a double-blind randomized controlled trial of 2546 patients

“…This study was a three-centre, two-arm, parallel-group, patient-and-assessor-blinded, quasi-randomized controlled trial with block treatment allocation conducted in the United Kingdom. The full details have been described previously, 25 and a summary of the methodology follows below. In this pragmatic trial, patients were eligible if they were aged > 18 years, medically fit for an operation and suitable for primary THA or TKA.…”

“…It was impossible, for practical reasons, to randomly allocate individuals to treatment groups and the best option was to randomize based on monthly blocks of time. 25 Envelopes were opened at the start of a month, so allocation was not known at the time of putting the patient on the waiting list, which was a mean of three months prior to surgery. The participating surgeons were not blinded to the allocation.…”

Bioactive Sutures: A Review of Advances in Surgical Suture Functionalisation

“…The use of bioactive sutures coated with antimicrobial drugs and anaesthetics have been shown to be effective in reducing inflammation and bacterial infection in the wound site [6,7].…”

Effect of Perioperative Bacteriological Safety on Hip Joint Infection after Hip Replacement

“…Kon tro wer sje do ty czą szcze gó łów re ali za cji "zasad asep ty ki" oko ło ope ra cyj nej w aspek cie pro ste go de cy do wa nia o po trze bie, ter mi nie i spo so bie de pi lacji po la ope ra cyj ne go, ro dza ju środ ków od ka ża ją cych skó rę, jak i sto so wa nia naj bar dziej za awan so wa nych tech nik oczysz cza ją cych po wie trze pod czas ope ra cji ty pu "la mi nar flow", jak rów nież sa na cji uzę bie nia [1,9,10]. Roz wa ża niu pod da je się ta kże sto so wa nie ni tek do szy cia za wie ra ją cych an ty sep tyk lub za sadność sto so wa nia po ope ra cyj ne go dre na żu ra ny [11,12]. Ma zur kie wicz i wsp.…”