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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 30 October 2017
Main ID:  ISRCTN74612906
Date of registration: 27/02/2017
Prospective Registration: Yes
Primary sponsor: Brighton and Sussex University Hospitals NHS Trust
Public title: Reducing implant infection in orthopaedics (RIIiO) pilot study
Scientific 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
Date of first enrolment: 01/04/2017
Target sample size: 700
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN74612906
Study type:  Interventional
Study design:  Randomised; Interventional; Design type: Process of Care, Management of Care, Surgery (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Matthew  Scarborough
Address:  Oxford University Hospitals Foundation NHS Trust Microbiology Level 7 John Radcliffe Hospital Headington OX3 9DU Oxford United Kingdom
Telephone: +44 1865 741166
Email: Matthew.Scarborough@ouh.nhs.uk
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. Provision of informed consent OR consultee declaration
2. Aged 60 years or over
3. Presenting with fracture of the hip
4. Scheduled to undergo hemiarthroplasty

Exclusion criteria: 1. Previous surgery or infection of the affected hip
2. Hip fractures related to polytrauma
3. Patients managed without hemiarthroplasty
4. Receiving an investigational medicinal product related to infection


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infection prevention; UKCRC code/ Disease: Infection/ Bacterial, viral and other infectious agents, Injuries and Accidents/ Injuries to the hip and thigh
Infections and Infestations
Infection following hip fracture
Intervention(s)
Participants are randomised to one of two groups in a 1:1 ratio using an online system (MACRO).

Resistive Fabric Warming (RFW) group: Participants receive Resistive Fabric Warming (RFW) during their surgery. RFW works like a low voltage electric blanket. A series of plastic coated, individually computer-controlled heating pads are used to warm the skin by direct contact. The pads can be placed both under the patient and over the parts of the body away from the operating site.

Forced Air Warming (FAW) group: Participants receive Forced Air Warming (FAW) during their surgery. FAW uses an electrical heater and a fan to blow warm air through a hollow paper duvet placed over the patient. There are holes in the duvet for the warm air to come out and heat the patient like a hair dryer. At the moment, most hospitals use this system.

Participants will be followed up for 90 days from the date of surgery by telephone contact and review of medical notes.
Primary Outcome(s)
1. Recruitment rate is recorded as the number of eligible participantswho consent to participate in the study within 90 days of surgery.
2. Definitive deep surgical site infection (SSI) rate is measured through clinical observations within 90 days of surgery
Secondary Outcome(s)
1. Superficial surgical site infection (SSI) rate is measured through clinical observations within 90 days of surgery
2. Inadvertent perioperative hypothermia (IPH) rate is assessed using temperature measurements during surgery
3. Health Economic assessment is assessed using length of hospital stay, patient reported outcome measures for quality of life score (EQ-5D-5L), resource utilisation and serious adverse events (SAEs) including death within 90 days of surgery
Secondary ID(s)
32470
Source(s) of Monetary Support
Healthcare Infection Society, 3M, Nuffield Benefaction for Medicine, Wellcome Institutional Strategic Support Fund (ISSF) at Oxford University
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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