Burn wound infections Infections and Infestations
Conditions
Interventions
Current intervention as of 27/11/2020:
Patients are admitted to QEHB following a burn injury, those with a burn =1% TBSA (Total Body Surface Area) that is colonised with bacteria and who meet the eli
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/11/2020: 1. At least one =1% TBSA burn injury prior to enrolment 2. Burn wound colonised with a specifically identifiable bacterium 3. Aged =16 years old 4. Anticipated to remain as inpatient for the study duration i.e. 3 days _____ Previous inclusion criteria as of 03/08/2018: 1. Patient to have a =1% TBSA burn injury/ies 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 _____ Previous 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 day
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 27/11/2020: 1. Burns solely to the face and/or genital area 2. Patients who have received acetic acid as part of standard therapy upon admission to inpatients for this burn injury 3. Patients deemed unsuitable to enter trial in the opinion of the investigator _____ Previous exclusion criteria as of 03/08/2018: 1. Patients who lack capacity to give informed consent (NB: translation services will be available for non-English speaking patients) 2. Patients who are on antibiotics for cellulitis 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 _____ Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/11/2020: Efficacy will be assessed by measuring the bacterial load from microbiology burn wound swabs taken daily from the beginning of treatment for 3 days Previous primary outcome measures: 1. Tolerability of acetic acid are assessed by measuring patients’ pain scores with a Visual Analogue Scale (VAS) over the 5 day treatment period 2. Efficacy of acetic acid are assessed by measuring the bacterial load from microbiology wound swabs, these will be taken daily from recruitment for 5 consecutive days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/11/2020: 1. Tolerability will be assessed by measuring a patient’s pain scores with a Visual Analogue Scale (VAS) on patients who have capacity to complete scores at each dressing change 2. The antimicrobial activity of acetic acid will be measured by extracting fluid from removed burns dressings at each dressing change and assessing the minimum inhibitory concentrations (MIC) to establish if active acetic acid is still present 3. Time to 95% healing of treated area 4. Perceived treatment allocation, assessed by asking patients after treatment completion which treatment they believed they received _____ Previous secondary outcome measures: 1. The antimicrobial activity of acetic acid are measured by extracting fluid from removed burns dressings and assessing the minimum inhibitory concentrations (MIC) to establish if active acetic acid is still present 2. Percentage of burn wound healed at 21 days (+/- 3 days) post burn injury 3. Perceived treatment allocation is assessed by asking patients after treatment completion (after the last dressing change on day 5) which treatment they believed they received | — |
Countries
England, United Kingdom
Outcome results
None listed