Condition category
Infections and Infestations
Date applied
20/02/2017
Date assigned
27/02/2017
Last edited
10/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

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 trial start date

29/01/2016

Overall trial 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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 700; UK Sample Size: 700

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

United Kingdom

Trial participating centre

Princess Royal Hospital
Brighton and Sussex University Hospitals NHS Trust, Lewes Road
Haywards Heath
RH16 4EX
United Kingdom

Trial participating centre

Horton General Hospital
Oxford University Hospitals Foundation NHS Trust, Oxford Road
Banbury
OX16 9AL
United Kingdom

Trial participating centre

Wansbeck General Hospital
Northumbria Healthcare NHS Trust, Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom

Trial participating centre

Milton Keynes University Hospital
Standing Way
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital site Herries Road
Sheffield
S5 7AU
United Kingdom

Trial 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

Trial 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
United Kingdom
+44 1273 696955
Scott.Harfield@bsuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.bsuh.nhs.uk/

Funders

Funder type

Research organisation

Funder name

Healthcare Infection Society

Alternative name(s)

HIS

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

3M

Alternative name(s)

3M Company

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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.

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.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/10/2017: The following changes were made to the trial record: 1. 3M and Nuffield Benefaction for Medicine and the Wellcome Institutional Strategic Support Fund (ISSF) at Oxford University were added as funders. 2. The target number of participants was changed from 300 to 700. 3. Trial participating centres added. 4. The intention to publish date was changed from 31/12/2018 to 31/12/2019.