Reducing implant infection in orthopaedics (RIIiO) pilot study

• Register: ISRCTN
• Last refreshed on: 7 October 2019
• 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: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Matthew Scarborough

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

Ethics review

Status:
Approval date:
Contact:

West Midlands - Coventry & Warwickshire Research Ethics Committee, 02/11/2016, ref: 16/WM/0451

Results

• Results available: Yes
• Date Completed: 31/03/2019