Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CH/2016/6025
Study information
Scientific title
Laboratory observational Ex-Vivo study to investigate the sensitivity and specificity of a smart dressing to detect clinically relevant wound infection
Acronym
EVIDEnT: Ex Vivo Infection DETection
Study hypothesis
The aim of this diagnostic accuracy study is to estimate the sensitivity, specificity, for the infection detection ‘smart’ technology.
Ethics approval
South West - Cornwall & Plymouth Research Ethics Committee, 02/09/2016, ref: 16/SW/0238
Study design
Multi-centre prospective ex-vivo diagnostic technology development study
Primary study design
Observational
Secondary study design
Laboratory study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
See additional files
Condition
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
Phase
Drug names
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 trial start date
01/06/2015
Overall trial end date
24/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
322 with suspected infection, and 100 controls (plus 20 with suspected infection, 10 controls for the pilot phase)
Participant 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
Recruitment start date
13/01/2017
Recruitment end date
26/04/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Royal Hospital for Children
Paul O'Gorman Building
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Trial participating centre
Southmead Hospital
Dorian Way
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Trial participating centre
Queen Victoria Hospital
Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
Trial participating centre
Chelsea and Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.
Intention to publish date
26/04/2019
Participant level data
Stored in repository
Basic results (scientific)
Publication list
Publication citations
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