Reducing implant infection in orthopaedics (RIIiO) pilot study
| ISRCTN | ISRCTN74612906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74612906 |
| Secondary identifying numbers | 32470 |
- Submission date
- 20/02/2017
- Registration date
- 27/02/2017
- Last edited
- 09/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Public
Oxford University Hospitals Foundation NHS Trust
Microbiology
Level 7
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 1865 741166 |
|---|---|
| Matthew.Scarborough@ouh.nhs.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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 |
| 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 |
Eligibility
| 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 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 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 centres
Lewes Road
Haywards Heath
RH16 4EX
United Kingdom
Oxford Road
Banbury
OX16 9AL
United Kingdom
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
Milton Keynes
MK6 5LD
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
St Peters Road
Margate
CT9 4AN
United Kingdom
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Sussex County Hosptial
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Phone | +44 1273 696955 |
|---|---|
| Scott.Harfield@bsuh.nhs.uk | |
| Website | https://www.bsuh.nhs.uk/ |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- HIS
- Location
- United Kingdom
Government organisation / For-profit companies (industry)
- Alternative name(s)
- 3M Company, 3M Science Applied to Life, 3M Science. Applied to Life. 3M United States, Minnesota Mining and Manufacturing Company
- Location
- United States of America
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
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 |
Editorial Notes
09/09/2019: Publication reference and total final enrolment added.
21/11/2018: Publication reference added.
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.
