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A clinical trial investigating the use of two different strengths of acetic acid in treating infected burn wounds.

Phase 1
Conditions
Colonised burn wounds
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
MedDRA version: 20.1 Level: PT Classification code 10053615 Term: Thermal burn System Organ Class: 10022117 - Injury, poisoning and procedural complications
MedDRA version: 20.0 Level: PT Classification code 10051548 Term: Burn infection System Organ Class: 10021881 - Infections and infestations
Registration Number
EUCTR2017-003481-28-GB
Lead Sponsor
niversity Hospitals Birmingham NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1. Patient to have a 1 - <10% TBSA burn injury prior to enrolment
2. Burn wound colonised with a specifically identifiable bacteria
3. Patients aged =18 years old
4. Patients who are anticipated to remain as inpatients for the study duration i.e. 5 days

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Patients who lack capacity to give informed consent (NB: translation services will be available for non-English speaking patients)
2. Patients who are receiving systemic antibiotics
3. Patients with burns solely to the face and/or genital area
4. Patients who have received acetic acid as part of standard therapy upon admission to inpatients for this burn injury
5. Patients deemed unsuitable to enter trial in the opinion of the investigator

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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