Wound healing in surgical trauma
| ISRCTN | ISRCTN12702354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12702354 |
| IRAS number | 192580 |
| Secondary identifying numbers | 5.0; HTA 14/199/14, IRAS 192580 |
- Submission date
- 07/12/2015
- Registration date
- 09/12/2015
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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 22 other hospitals
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
Contact information
Scientific
NDORMS
Kadoorie Centre- John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223114 |
|---|---|
| WHIST@ndorms.ox.ac.uk |
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| 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 contact details to request a participant information sheet |
| 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 |
| Study acronym | WHIST |
| Study objectives | 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(s) | West Midlands - Coventry and Warwickshire REC, 16/02/2016, ref: 16/WM/0006 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 | Current secondary outcome measures (as of 18/12/2017): 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, chronic neuropathic pain and quality of life are determined using the Disability Rating Index (DRI), Neuropathic Pain 4 Questions (DN4) and EuroQol (EQ-5D-5L) respectively at 1, 2, 3, 4 and 5 years post-injury Previous 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 study start date | 01/01/2016 |
| Completion date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 1540 |
| Total final enrolment | 1548 |
| Key inclusion criteria | Current participant inclusion criteria (as of 18/12/2017): 1. Aged 16 years or older 2. Present to 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 lower limb fracture requiring a surgical incision Previous 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 |
| Key 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 |
| Date of first enrolment | 07/07/2016 |
| Date of final enrolment | 17/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Oxford
OX3 9DU
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Frenchay Park Road
Bristol
BS16 1JE
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Derby Road
Nottingham
NG7 2UG
United Kingdom
Middlesborough
TS4 3BW
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Liverpool
L9 7AL
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
London
SE5 9RS
United Kingdom
Leeds
LS1 3EX
United Kingdom
Leicester
LE1 5WW
United Kingdom
Sheffield
S5 7AU
United Kingdom
Plymouth
PL6 8DH
United Kingdom
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Eastern Road
Brighton
BN2 5BE
United Kingdom
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Newcastle-upon-Tyne
NE1 4LP
United Kingdom
London
SW17 0RE
United Kingdom
Paddington
London
W2 1NY
United Kingdom
Salford
M6 8HD
United Kingdom
Southampton
SO16 6YD
United Kingdom
Penlan Road
Penarth
CF64 2XX
United Kingdom
Sponsor information
University/education
Joint Research Office
Churchill Hospital
Block 60
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/06/2018 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 28/03/2019 | No | No | |
| Results article | results | 11/02/2020 | 12/02/2020 | Yes | No |
| Results article | results | 01/08/2020 | 25/08/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | Cost analysis and pain medication use | 15/06/2023 | 21/01/2025 | Yes | No |
Editorial Notes
21/01/2025: Publication reference added.
25/08/2020: Publication reference added.
19/02/2020: The IRAS number has been added.
12/02/2020: Publication reference and total final enrolment number added.
01/04/2019: Publication references added.
24/07/2018: The following changes were made to the trial record:
1. Addenbrooke's Hospital, University Hospital Aintree, Hull Royal Infirmary, Kings College Hospital, Leeds General Infirmary, Leicester General Infirmary, Northern General Hospital, Derriford Hospital, Queen Elizabeth Hospital, Royal London Hospital, Brighton and Sussex University Hospitals, Royal Stoke University Hospital, Royal Victoria Infirmary, St George's University of London, St Mary's Hospital, Salford Royal NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust and Cardiff and Vale Orthopaedic Centre (CAVOC) were added as trial participating centres.
2. The plain English summary was updated
23/07/2018: The intention to publish date was changed from 31/07/2018 to 31/07/2019.
20/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2018 to 17/04/2018
2. The intention to publish date was changed from 31/07/2019 to 31/07/2018
18/12/2017: The following changes were made:
1. The protocol number was changed from 2.0 to 5.0.
2. Recruitment end date was changed from 31/01/2018 to 31/03/2018.
3. Participant inclusion criteria and secondary outcome measures were updated.
15/08/2016: the recruitment start date was changed from 01/04/2016 to 07/07/2016.
31/03/2016: ethics approval information added.
