Condition category
Musculoskeletal Diseases
Date applied
07/12/2015
Date assigned
09/12/2015
Last edited
15/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Major trauma is where a person has sustained serious and often multiple injuries. In many cases, it is the result of traffic accidents, falls and physical violence, and is one of the most common causes of death and long-term disability in people under the age of 45. Leg injuries are particularly common in cases of major trauma, and many patients require surgery to help fix broken bones. Many patients suffer from infection in surgical sites however in victims of major trauma this is thought to be as high as 40%. This is thought to be because the extensive damage to the muscles and other tissues can make patients’ tissues less resistant to bacteria and more vulnerable to infection. Deep infection around the bone causes long-term problems for the patient, often required repeated operations and can even lead to amputation of the limb. Wound dressings are commonly used to prevent infections of surgical sites in adults; however the type of dressing used could reduce the risk of infection. New dressings are constantly being developed, however these are often introduced into the NHS without any formal testing in research projects. Negative pressure wound therapy (NPWT) is a technique which involves applying gentle suction to the surface of the wound as it heals. The aim of this study is to test the effectiveness of NPWT in comparison to standard dressings, at reducing rates of surgical site infections in major trauma patients.

Who can participate?
Major trauma patients aged 16 or over who need surgery to treat a broken leg.

What does the study involve?
Following surgery, participants are randomly allocated to one of two groups. For participants in the first group, the surgical wounds are dressed with a NPWT dressing. This consists of a foam pad, which is connected to a mini-pump to create a partial vacuum over the wound. For participants in the second group, their surgical wounds are dressed using an ordinary dressing which does not use negative pressure. 30 days after the injury occurred, the amount of participants who have had a deep infection is recorded. At the start of the study and again at 3 and 6 months, participants complete a number of questionnaires in order to measure their level of disability and quality of life, as well as how well their wound is healing. Their long-term disability and quality of life is also measured using a questionnaire at 1, 2, 3, 4 and 5 years.

What are the possible benefits and risks of participating?
There are no direct risks or benefits to participants taking part in the study.

Where is the study run from?
John Radcliffe Hospital, Oxford (lead centre) and five other NHS hospitals in England (UK) for the pilot phase

When is the study starting and how long is it expected to run for?
January 2016 to April 2023

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Juul Achten
WHIST@ndorms.ox.ac.uk

Trial website

www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/whist

Contact information

Type

Scientific

Primary contact

Dr Juul Achten

ORCID ID

Contact details

NDORMS
Kadoorie Centre- John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 223114
WHIST@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0; HTA 14/199/14

Study information

Scientific title

A randomised controlled trial of standard wound management versus negative pressure wound therapy in the treatment of adult patients having surgical incisions for major trauma to the lower limb

Acronym

WHIST

Study hypothesis

The aim of this study is to compare the effectiveness of negative-pressure wound therapy with standard dressings for patients with major trauma requiring surgical incisions for the treatment of lower limb fractures.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1419914
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/161986/PRO-14-199-14.pdf

Ethics approval

West Midlands - Coventry and Warwickshire REC, 16/02/2016, ref: 16/WM/0006

Study design

Multi-centre randomised controlled trial

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 contact details to request a participant information sheet

Condition

Patients with major trauma requiring surgery for a fracture to the lower limb.

Intervention

Patients with a fracture of the lower limb associated with major trauma usually have surgery on the next available trauma operating list. Some patients may be transferred to a Major Trauma Centre for definitive care – within the first 48 hours of injury – but will still have their initial surgery as soon as possible. All patients will receive a general or regional anesthetic. At the end of the initial operation, participants are randomly allocated to one of two groups.

Control Group: Participants receive standard of care wound dressing. The standard dressing for a surgical wound comprises a non-adhesive layer applied directly to the wound which is covered by a sealed dressing or bandage. The standard dressing does not use ‘negative pressure’. The exact details of the materials used will be left to the discretion of the treating surgeon as per their routine practice but the details of each dressing applied in the trial will be recorded.

Intervention group: 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 etc to be removed – 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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Deep infection rate in lower limbs is measured 30 days post-injury by the patient’s treating clinical team using the Centre for Disease Control and Prevention definition of a deep surgical site infection.

Secondary outcome measures

1. Disability and quality of life are measured using the Disability Rating Index and the EQ-5D-5L at baseline (retrospective) and 3 and 6 months post-injury
2. Wound healing is measured using a validated patient reported questionnaire at 30 days, 3 and 6 months post-injury
3. Number and nature of further surgical interventions is assessed using patients medical records and patient self-report at 30 days, 3 and 6 months
4. Cost effectiveness is determined using national databases and patient resource questionnaires at 3 and 6 months post-injury
5. Long-term disability and quality of life is determined using the Disability Rating Index at 1, 2, 3, 4 and 5 years post-injury

Overall trial start date

01/01/2016

Overall trial end date

30/04/2023

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years or older
2. Present to the trial hospital within 72 hours of injury
3. Presence of major trauma (as defined by eligibility for the UK Trauma Audit Research Network (TARN) database)
4. Presence of a limb fracture requiring a surgical incision

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1540

Participant exclusion criteria

1. An open fracture of the lower limb which cannot be closed primarily
2. There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires

Recruitment start date

07/07/2016

Recruitment end date

31/01/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way
Oxford
OX3 9DU
United Kingdom

Trial participating centre

University Hospital
University Hospitals Coventry and Warwickshire NHS trust Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Frenchay Hospital
North Bristol NHS trust Frenchay Park Road
Bristol
BS16 1JE
United Kingdom

Trial participating centre

North Tyneside General Hospital
Northumbria Healthcare NHS Foundation Trust Rake Lane
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Queen's Medical Centre
Nottingham University Hospitals NHS trust Derby Road
Nottingham
NG7 2UG
United Kingdom

Trial participating centre

The James Cook University Hospital
Marton Road
Middlesborough
TS4 3BW
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

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

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 in Summer 2019. The results of the long follow-up will be presented and published in the summer of 2023.

Intention to publish date

31/07/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/08/2016: the recruitment start date was changed from 01/04/2016 to 07/07/2016. 31/03/2016: ethics approval information added.