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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13825483
Enrollment
422
Registered
2016-12-09
Start date
2017-01-13
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn wound infection Skin and Connective Tissue Diseases Burn wound infection

Interventions

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 rou

Sponsors

University Hospitals Bristol NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Levels of bacterial toxins to validate both clinical definition of wound infection and technology switch-on is measured using qPCR at baseline.

Countries

United Kingdom

Contacts

Public ContactNatasha Iles

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026