aboratory observational Ex-Vivo study to investigate the sensitivity and specificity of a smart dressing to detect clinically relevant wound infectio

Not Applicable

Completed

• Conditions: Burn wound infection; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN13825483
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

2021 Preprint results in https://www.medrxiv.org/content/10.1101/2021.07.21.21260922v1 preprint results (added 17/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Study Completion: 2018-04-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 344

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Technology switched on or remained off is measured by observing colour change in the laboratory at baseline<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
evels of bacterial toxins to validate both clinical definition of wound infection and technology switch-on is measured using qPCR at baseline.