Laboratory observational Ex-Vivo study to investigate the sensitivity and specificity of a smart dressing to detect clinically relevant wound infection
| ISRCTN | ISRCTN13825483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13825483 |
| Secondary identifying numbers | CH/2016/6025 |
- Submission date
- 24/10/2016
- Registration date
- 09/12/2016
- Last edited
- 17/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Burn wound infections are difficult to diagnose, but may become serious if they are not treated quickly. To diagnose an infection, dressings need to be removed from the wound, which may slow the healing process. A new dressing Smartwound™ may help to diagnose wound infection without needing to remove the dressing. The Smartwound™ dressing changes colour in the presence of the infection-causing bacteria. Laboratory studies show that the dressing does change colour in the presence of bacteria, but before it can be used in patients, it needs to be tested with the bacteria found in human wounds. The new Smartwound™ dressing will not be tested on patients in this study. Samples of burn wound fluid, called exudate, which can be taken from wound swabs and used wound dressings when the patients have their dressings removed will be used. Exudate will be gathered from patients with and without wound infection to see whether the dressing changes colour in the presence of the bacteria that cause a wound infection. Dressing changes and swabs are part of the normal care routine for patients with burns. This study aims to test whether the Smartwound™ technology developed to detect infection in a dressing for burn wounds is effective in identifying infection.
Who can participate?
Patients with burn wounds who either have a suspected infection requiring a dressing change and patients with a burn injury with no signs of an infected wound.
What does the study involve?
Old standard dressings are collected from patients along with some samples of the burn wound exudate/biofilm (burn wound fluid) using gauze and two cotton swabs. The samples of exudate are taken from the patients during routine treatment. This may be when they are in theatre or in the treatment area, when the wound is being cleaned. The new Smartwound™ dressing is not being tested on patients. The exudate samples are used to test the Smartwound™ dressing in the laboratory. Some medical information relating to the burn wound is collected. Patients are followed up at 14- 21 days to gain information about antibiotic treatment, dressings, additional medical help and the healing of the burn wound. This is done either at scheduled clinic appointments as part of normal care, or by telephone.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those participating.
Where is the study run from?
1. Bristol Royal Hospital for Children (UK)
2. Southmead Hospital (UK)
3. Queen Victoria Hospital in East Grinstead (UK)
4. Chelsea and Westminster Hospital (UK)
When is study starting and how long is it expected to run for?
June 2015 to April 2018
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Natasha Iles
BSCTUEvident@bsms.ac.uk
Contact information
Public
Brighton and Sussex Clinical Trials Unit
Room 204 Bevendean House
University of Brighton
Brighton
BN1 9PH
United Kingdom
Study information
| Study design | Multi-centre prospective ex-vivo diagnostic technology development study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Laboratory study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN13825483_PIS_30Sep16_V2.2_Parent.pdf |
| Scientific title | Laboratory observational Ex-Vivo study to investigate the sensitivity and specificity of a smart dressing to detect clinically relevant wound infection |
| Study acronym | EVIDEnT: Ex Vivo Infection DETection |
| Study objectives | The aim of this diagnostic accuracy study is to estimate the sensitivity, specificity, for the infection detection ‘smart’ technology. |
| Ethics approval(s) | South West - Cornwall & Plymouth Research Ethics Committee, 02/09/2016, ref: 16/SW/0238 |
| Health condition(s) or problem(s) studied | Burn wound infection |
| Intervention | The old dressing and exudate soaked gauze will be sent to the laboratory at University of Bath to assess the smart wound technology ‘switch-on’ i.e. colour change. A standard swab will be sent for routine hospital microbiology analysis (MC+S) and a clinical assessment of wound infection by observation will be performed. A swab will also be sent to the laboratory at University of Brighton for qPCR testing to determine the levels of bacterial toxins present to validate the technology responsiveness and the clinical definition of would infection. The patient will be followed up by means of a telephone call or face-to-face if they have a routine visit scheduled at 14-21 days for a retrospective confirmation of whether the wound was infected or not. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Technology switched on or remained off is measured by observing colour change in the laboratory at baseline 2. Clinically relevant wound infection or no infection is assessed using clinical decisions, taking into account observation of wound, laboratory markers of inflammation and infection, wound and blood microscopy and culture and response to antibiotics at baseline. A follow-up review at 14-21 days will be carried out to confirm retrospectively the wound infection assessment at baseline. |
| Secondary outcome measures | Levels of bacterial toxins to validate both clinical definition of wound infection and technology switch-on is measured using qPCR at baseline. |
| Overall study start date | 01/06/2015 |
| Completion date | 24/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 322 with suspected infection, and 100 controls (plus 20 with suspected infection, 10 controls for the pilot phase) |
| Total final enrolment | 344 |
| Key inclusion criteria | Control group 1. Patients with burns of all types and sizes 2. Any child from 4 weeks up to the age of 16 years/adults up to 100 years 3. >48 hrs after injury but before healing complete 4. Wound dressings intact 5. No signs of wound infection 6. Not currently using antibiotics 7. Consent gained for study Suspected infection group 1. Patients who present with a suspected burn wound infection as determined by the reference standard. 2. A child/adult with burns 3. Any child from 4 weeks up to the age of 16 years/adults up to 100 years 4. Wound dressings intact 5. Not on antibiotics for longer than 24 hours 6. Consent gained for study |
| Key exclusion criteria | All participants: 1. Child < four weeks of age/adults above 100 years 2. Consent not gained for study 3. Adult without mental capacity to consent 4. A child/adult who is on antibiotics for longer than 24 hours 5. No wound dressings |
| Date of first enrolment | 13/01/2017 |
| Date of final enrolment | 26/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
London
SW10 9NH
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Education & Research Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 26/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.2 | 30/09/2016 | 09/12/2016 | No | Yes |
| Participant information sheet | version V2.2 | 30/09/2016 | 09/12/2016 | No | Yes |
| Participant information sheet | version V2.2 | 30/09/2016 | 09/12/2016 | No | Yes |
| Participant information sheet | version V2.2 | 30/09/2016 | 09/12/2016 | No | Yes |
| Preprint results | preprint results | 23/07/2021 | 17/08/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13825483_PIS_30Sep16_V2.2_Parent.pdf
- Uploaded 09/12/2016
- ISRCTN13825483_PIS_30Sep16_V2.2_Childunder10.pdf
- Uploaded 09/12/2016
- ISRCTN13825483_PIS_30Sep16_V2.2_Child10-16.pdf
- Uploaded 09/12/2016
- ISRCTN13825483_PIS_30Sep16_V2.2_Adult.pdf
- Uploaded 09/12/2016
Editorial Notes
17/08/2021: The following changes have been made:
1. Preprint reference added.
2. The total final enrolment number has been added from the reference.
31/10/2019: Internal review.
22/05/2019: Internal review.
12/05/2017: The recruitment start date has been updated from 26/10/2016 to 13/01/2017
