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Clinical Trials/ISRCTN11636684
ISRCTN11636684
Completed
Phase 2

A pilot randomised controlled trial to examine the efficacy and optimal dose of acetic acid to treat colonised burns wounds

niversity Hospitals Birmingham NHS Foundation Trust0 sites22 target enrollmentJanuary 29, 2018

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Birmingham NHS Foundation Trust
Enrollment
22
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37748846/ (added 26/09/2023)

Registry
who.int
Start Date
January 29, 2018
End Date
January 4, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals Birmingham NHS Foundation Trust

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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