Condition category
Skin and Connective Tissue Diseases
Date applied
24/10/2016
Date assigned
09/12/2016
Last edited
15/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Dr Natasha Iles

ORCID ID

Contact details

Brighton and Sussex Clinical Trials Unit
Room 204 Bevendean House
University of Brighton
Brighton
BN1 9PH
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust

Sponsor details

Research & Innovation
Education & Research Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

12/05/2017: The recruitment start date has been updated from 26/10/2016 to 13/01/2017