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Reducing implant infection in orthopaedics (RIIiO) pilot study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74612906
Enrollment
700
Registered
2017-02-27
Start date
2017-04-01
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Infectious diseases and microbiology, Primary sub-specialty: Infection prevention

Interventions

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 (RF

Sponsors

Brighton and Sussex University Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Contacts

Public ContactMatthew Scarborough
Matthew.Scarborough@ouh.nhs.uk+44 1865 741166

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026