Condition category
Musculoskeletal Diseases
Date applied
31/05/2017
Date assigned
31/05/2017
Last edited
20/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 August 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 (0)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 (0)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 measure

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

17/08/2018

Reason abandoned (if study stopped)

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

22/02/2018

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

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials Research and Governance
Joint Research Office
Churchill Hospital
Block 60
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

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.

Intention to publish date

01/04/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/07/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/03/2018 to 22/02/2018. 2. The overall trial end date was changed from 01/12/2018 to 17/08/2018. 3. The intention to publish date was changed from 01/12/2019 to 01/04/2019. 26/01/2018: The recruitment end date has been updated from 30/11/2017 to 01/03/2018. Bristol Southmead Hospital has been added as a trial participating site. 01/06/2017: Verified study information with principal investigator.