Reducing Implant Infection in Orthopaedics (RIIiO) Pilot Study (v1.0)
Research type
Research Study
Full title
Pilot Study for a trial comparing the influence of forced air versus resistive fabric warming technologies on post-operative infection rates following orthopaedic implant surgery in adults.
IRAS ID
197521
Contact name
Matthew Scarborough
Contact email
Sponsor organisation
Brighton and Sussex University Hospitals NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
There are currently about 70,000 operations to repair hip fractures per year in the UK. Approximately 2.5% of these are complicated by deep post-operative surgical site infection (SSI). This usually mandates repeat surgery, substantial rehabilitation, and prolonged antibiotic therapy with the associated risk of emergent antibiotic resistance. Treatment costs are estimated at £20,000-£40,000 and patient reported outcomes and long term survival are significantly worse as compared to those who do not develop an SSI. The risk of SSI is reduced by preventing hypothermia during surgery. We hypothesise that post-operative infection rates are influenced by the system used to keep patients warm. Observational data suggest that, by replacing forced air warming (FAW) - the most commonly used method - with direct contact resistive fabric warming (RFW), the incidence of post-operative infections could be reduced by >40%. Confirmation of this requires a prospective, multi-centre, randomised clinical trial. Participants will be randomised to either FAW or RFW and followed up for 90 days. All data required will be available from routine clinical records or by telephone contact after discharge. No trial-specific investigations or clinic visits are required. If RFW is shown to be associated with fewer infections than FAW, it is likely that practice will change nationally, patient outcomes will improve and significant savings will be made for the NHS. The biggest barrier to successful funding for a trial of this kind is the number of participants required. An absolute reduction of 1% in post-operative infection rate, using a 5% significance level and allowing for up to 10% loss to follow-up, requires approximately 9,000 participants. In order to inform recruitment rates, number of sites required and data management strategy, we will conduct a pilot study across a limited number of NHS sites over 2 years. Pilot data will be transferred to the full trial.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0451
Date of REC Opinion
2 Nov 2016
REC opinion
Favourable Opinion