Plain English Summary
Background and study aims
Hip fractures affect 70 000 patients per year in the UK, and it is predicted that 100 000 people will suffer a hip fracture in the UK by 2020. Almost all patients undergo surgery to enable them to start walking again. However, between 2% and 7% of patients will get a wound infection. These infections are very serious and lead to a much longer hospital stay, more surgery and for half of the patients-death. In surgery, the use of negative pressure wound therapy (NPWT)-a type of suction dressing-is increasing rapidly. However it has not been tested rigorously in a formal trial, and it has not been looked at for hip fracture surgery specifically. The aim of this study is to better understand the rates of the infection problem in hip fracture surgery and to explore whether it will be feasible to run a large multicentre trial comparing NPWT with normal wound dressings.
Who can participate?
Adults aged 65 years or older who have a hip fracture that requires surgery
What does the study involve?
Participants who require surgery are randomly allocated to one of two groups. Both groups undergo the surgery. Those in the first group have the standard wound dressing applied after their wound is closed during surgery done to the standard level of care. Those in the second group receive a negative pressure wound therapy (NPWT) dressing. This uses solid foam laid on to the wound connected to a pump that creates a vacuum over the wound. Participants have their dressings on the wound until they need their stitches removed around one to two weeks after surgery. However, if they need to be re-dressed then this is recorded. Participants are assessed to see whether they develop an infection as well as the routine questions that are asked of all people who break their hip.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
March 2017 to December 2018
Who is funding the study?
1. National Institute for Health Research (UK)
2. Royal College of Surgeons of England (UK)
Who is the main contact?
Mrs Lucy Sansom
lucy.sansom@ndorms.ox.ac.uk
Trial website
ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/white7
Contact information
Type
Public
Primary contact
Miss Lucy Sansom
ORCID ID
Contact details
University of Oxford
Oxford
OX3 7LE
United Kingdom
+44 1865 227903
lucy.sansom@ndorms.ox.ac.uk
Type
Scientific
Additional contact
Mr James Masters
ORCID ID
http://orcid.org/0000-0001-9663-8858
Contact details
Kadoorie Centre
Level 3
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom
+44 1865 223114
WHISH@ndorms.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
34527
Study information
Scientific title
A randomised controlled feasibility trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for hip fractures
Acronym
WHISH
Study hypothesis
Research Question:
To quantify the difference in the rate of deep infection after hip fracture surgery between patients using standard wound dressings and patients using Negative Pressure Wound Therapy (NPWT) dressings. This will in turn be used to define the sample size of a definitive multicentre randomised controlled trial.
Null hypotheses:
1. The rate of deep infection after 30 days, according to the CDC definition, will not be significantly different between the two patient groups
2. There will be no diiference in mortality rate between the two patient groups
3. The number and nature of further surgical interventions related to the injury will not be significantly different between the two patient groups
4. There will be no difference in the distribution of patient-reported functional outcome and quality of life measures between the patient groups
Ethics approval
Oxford C Research Ethics Committee, 28/04/2017, 17/SC/0207
Study design
Randomised; Interventional; Design type: Treatment, Device, 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: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh, Infection/ Other infectious diseases
Intervention
Patients with a fracture of the hip will present at the trial centres to undergo surgery on the next planned trauma operating list. At the end of their surgery they will be randomised to one of two groups via the use of a centralised computer randomisation service RRAMP (https://rramp.octru.ox.ac.uk) provided by the Oxford Clinical Trials Research Unit (OCTRU). Randomisation will be stratified by centre to ensure the participants from each study site have an equal chance of receiving each intervention.
Group 1: Participants have the standard wound dressing applied after closure of the wound during surgery as per local hospital procedures.
Group 2: Participants receive a negative pressure wound therapy (NPWT) dressing. The NPWT dressing uses an ‘open-cell’, solid foam which is laid onto the wound as an intrinsic part of a sealed dressing. A sealed tube connects the dressing to a built in mini-pump which creates a partial vacuum over the wound.
In most cases the first dressing applied to the wound at the end of the operation is left in place until the wound is ready for the stitches to be removed which is usually one to two weeks after the surgery. However, in some cases, depending upon the specific injury and according to the treating surgeons’ normal practice, the wound may be re-dressed again on the ward. Any further wound dressing will be recorded and will follow the allocated treatment unless otherwise clinically indicated.
Participants are assessed to see whether they develop an infection as well as the routine questions that are asked of all people who break their hip.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Deep Infection, using the Center for Disease Control and Prevention definition of a “deep surgical site infection”; that is a wound infection involving the tissues deep to the skin that occurs within 30 days post surgery
Secondary outcome measures
1. Rate of Mortality
2. Health-related quality of life is measured using the EuroQol EQ-5D-5L questionnaire at baseline and 4 months post-surgery
3. Complications and surgical interventions related to the index wound are measured using questionnaires at 4 months
4. Cost consequences and resource use (NHS costs, patient's out-of-pocket expenses) are measured using a short questionnaire at four months post injury
5. Mobility is measured using questionnaires at the baseline and 4 month CRF
6. Residential status is measured using questionnaire at baseline and at 4 months
7. Recruitment rate is measured using questionnaire at baseline
8. Retention rate is measured using screening logs at baseline
The core outcome set available via [http://www.comet-initiative.org/studies/details/274] has been consulted in the construction of the study outcome measures
Overall trial start date
01/03/2017
Overall trial end date
01/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients aged 65 years or older
2. Patients that have a hip fracture requiring surgical treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 464; UK Sample Size: 464
Participant exclusion criteria
Patients having percutaneous screw fixation of an undisplaced intracapsular fracture of the hip.
Recruitment start date
15/06/2017
Recruitment end date
01/03/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Oxford
Clinical Trials Research and Governance
Joint Research Office
Churchill Hospital
Block 60
Oxford
OX3 7LE
United Kingdom
Trial participating centre
Poole Hospital
Poole Longfleet Road
Poole
BH15 2JB
United Kingdom
Trial participating centre
Norfolk & Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom
Trial participating centre
Nottingham Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom
Trial participating centre
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
Royal College of Surgeons of England
Alternative name(s)
RCS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of the main phase of the study are likely to be presented at (inter)national conferences and in peer-reviewed journals.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date-my study sits within a cohort which I am not sole owner so it is not for me to commit data there without permission from the CI of the cohort. However our group believe in the principle of open publishing of data.
Intention to publish date
01/12/2019
Participant level data
Not expected to be available
Results - basic reporting
Publication summary