Plain English Summary
Background and study aims
A hip fracture is where there is a break in the upper thigh bone (femur). They are more common in older people as they are more likely to have weakened, brittle bones (osteoporosis) and tend to result from a fall. In most cases, surgery is the only treatment option for hip fractures. There are currently about 70,000 operations to repair hip fractures per year in the UK. In around 2.5% of these procedures, patients develop serious infections in the surgical cut (deep post-operative surgical site infection). This can lead to the need for further surgery, problems with recovery and long-term treatment with antibiotics. The risk of developing a surgical site infection (SSI) is reduced by preventing the body from becoming too cold (hypothermia) during surgery. The aim of this study is to find out whether the system used to keep patients warm during surgery influences the number who go on to develop SSI.
Who can participate?
Adults aged 60 and over who have a hip fracture and are scheduled to have a hip replacement surgery.
What does the study involve?
Participants are randomly allocated to one of two groups. All patients receive surgery as normal, but with a different warming system used during the procedure. Those in the first group receive Resistive Fabric Warming (RFW) during their surgery, which works like a low voltage electric blanket. This involves using a series of plastic coated, individually computer-controlled heating pads to warm the skin. Those in the second group receive Forced Air Warming (FAW) during their surgery. This involves using 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. This is the usual method of warming used by hospitals. Participants in both groups are contacted one and three months after their surgery to assess their wellbeing. In addition, medical records are reviewed by the research team to find out how many in each group develop SSIs and how serious any infections are.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating, as the systems used in this study are currently being used in NHS hospitals and are equally good at keeping patients warm during surgery.
Where is the study run from?
1. Princess Royal Hospital, Haywards Heath (UK)
2. Horton General Hospital, Banbury (UK)
3. Wansbeck General Hospital, Ashington (UK)
4. Milton Keynes University Hospital (UK)
5. Sheffield Teaching Hospitals NHS Foundation Trust (UK)
6. East Kent Hospitals University NHS Foundation Trust (UK)
7. Heart of England NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2016 to March 2019
Who is funding the study?
Healthcare Infection Society, 3M and Nuffield Benefaction for Medicine and the Wellcome Institutional Strategic Support Fund (ISSF) at Oxford University (UK)
Who is the main contact?
Dr Matthew Scarborough
Matthew.Scarborough@ouh.nhs.uk
Study website
Contact information
Type
Public
Contact name
Dr Matthew Scarborough
ORCID ID
Contact details
Oxford University Hospitals Foundation NHS Trust
Microbiology
Level 7
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 1865 741166
Matthew.Scarborough@ouh.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
32470
Study information
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
Acronym
RIIiO
Study hypothesis
The aim of this study is to investigate whether the risk of post-operative orthopaedic implant infection is influenced by the choice of intraoperative warming technology.
Ethics approval(s)
West Midlands - Coventry & Warwickshire Research Ethics Committee, 02/11/2016, ref: 16/WM/0451
Study design
Randomised; Interventional; Design type: Process of Care, Management of Care, Surgery
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Intervention
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.
Intervention type
Other
Primary outcome measure
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 measures
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
Overall study start date
29/01/2016
Overall study end date
31/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
Planned Sample Size: 700; UK Sample Size: 700
Total final enrolment
515
Participant 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
Recruitment start date
01/04/2017
Recruitment end date
31/12/2018
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Princess Royal Hospital
Brighton and Sussex University Hospitals NHS Trust
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom
Study participating centre
Horton General Hospital
Oxford University Hospitals Foundation NHS Trust
Oxford Road
Banbury
OX16 9AL
United Kingdom
Study participating centre
Wansbeck General Hospital
Northumbria Healthcare NHS Trust
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
Study participating centre
Milton Keynes University Hospital
Standing Way
Milton Keynes
MK6 5LD
United Kingdom
Study participating centre
Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital site
Herries Road
Sheffield
S5 7AU
United Kingdom
Study participating centre
East Kent Hospitals University NHS Foundation Trust
Based at: Queen Elizabeth the Queen Mother Hospital
St Peters Road
Margate
CT9 4AN
United Kingdom
Study participating centre
Heart of England NHS Foundation Trust
Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
Brighton and Sussex University Hospitals NHS Trust
Sponsor details
Royal Sussex County Hosptial
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
+44 1273 696955
Scott.Harfield@bsuh.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Healthcare Infection Society
Alternative name(s)
HIS
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Funder name
3M
Alternative name(s)
3M Company, 3M Science Applied to Life, 3M Science. Applied to Life. 3M United States, Minnesota Mining and Manufacturing Company
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Funder name
Nuffield Benefaction for Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wellcome Institutional Strategic Support Fund (ISSF) at Oxford University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal and at scientific conferences in 2019.
Intention to publish date
31/12/2019
Individual participant data (IPD) Intention to share
No
IPD sharing plan
As this trial is designed as an pilot study, the investigators will not have unrestricted access to the raw data. If the pilot leads on to a definitive trial, data sharing may be possible dependent on contractual obligations.
IPD sharing plan summary
Not expected to be made available
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/11/2018 | Yes | No | |
| Results article | results | 01/12/2019 | 09/09/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |