Condition category
Injury, Occupational Diseases, Poisoning
Date applied
18/12/2017
Date assigned
29/01/2018
Last edited
29/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Burn wound infections (BWI) can cause delayed healing of burns, poor scarring and infection leading to sepsis. Acetic acid is more commonly known as vinegar and has been used as an antibacterial agent for thousands of years. More recently it has been a widely used antiseptic agent for use on skin for the treatment of burns wounds and has been shown to have activity against certain bacterial infections within the wounds. During the treatment of these wounds, it is important to maintain a balance between effective removal of bacteria and how well patients tolerate the acetic acid. It is documented that many patients complain of stinging and pain on application of acetic acid to wounds, in particular if a strength of 5% concentration is used. The study will assess how two different strengths of acetic acid (0.5 and 2% concentrations) are tolerated by patients who have been admitted to hospital with burn wound infections. The study aims to establish the optimal dose of acetic acid for treating colonised burns wounds. The burns wounds will require to be colonised with a specifically identifiable bacteria and bacteria load will be studied by the microbiology department. Wound exudate extracted for burns dressing will be examined alongside routine burns swabs to extract detailed data of bacterial load and acetic acid presence.

Who can participate?
Adults aged 18 and older who have a burn injury.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have their burns treated via dressings soaked in 0.5% acetic acid solution. Those in the second group have their burns treated via dressings soaked in 2% acetic acid solution. Participants undergo twice daily dressing changes for a period of five days (except on day three when only one dressing change will take place). There is a total of nine dressing changes throughout the study period, which are equivalent to standard-of-care for these patients. The duration of the study also fall under the patient's standard-of-care. At each dressing change patients are asked to record their pain experience prior to analgesia, post burn wound cleaning and prior to treatment, immediately post treatment and 30 minutes post treatment. The dressings removed from patients containing wound exudate are then sent to the microbiology laboratory for further testing and examination. The burn wound surface pH are also measured during each dressing change as this there is evidence to suggest that wound surface pH correlates to the time of healing. Once daily (during the morning dressing change) participants also have a microbiology wound swab taken from their burn wounds. Participants are followed up at day 21 post burn injury, which fall in line with their standard of care hence participants have not have to attend this solely for trial-specific purposes.

What are the possible benefits and risks of participating?
There are no known additional benefits for being a participant in the study, but by testing out these lower concentrations of acetic acid in treating burns wounds this may lead to patients experiencing less pain and stinging if these concentrations are found to be as effective (as higher concentrations currently used) and are used as standard treatment in the future.

Where is the study run from?
Queen Elizabeth Hospital Birmingham (UK)

When is the study starting and how long is it expected to run for?
February 2017 to August 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Amrita Athwal (Scientific)
a.k.athwal@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Amrita Athwal

ORCID ID

Contact details

D3B Team (Drugs
Devices
Diagnostics and Biomarkers)
5th Floor
Open Plan EAST
ITM
Heritage Building
Mindelson Way
Edgbaston
Birmingham
B15 2TH
United Kingdom
+44 121 371 8459
a.k.athwal@bham.ac.uk

Additional identifiers

EudraCT number

2017-003481-28

ClinicalTrials.gov number

Protocol/serial number

36451

Study information

Scientific title

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

Acronym

AceticA

Study hypothesis

The study aims to establish the optimal dose of acetic acid for treating colonised burns wounds. The burns wounds will require to be colonised with a specifically identifiable bacteria and bacteria load will be studied by the microbiology department. Wound exudate extracted for burns dressing will be examined alongside routine burns swabs to extract detailed data of bacterial load and acetic acid presence.

Ethics approval

West Midlands – Edgbaston REC Committee, 21/12/2017, ref: 17/WM/0407

Study design

Randomised; Interventional; Design type: Treatment, Other

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet: SRMRC Research team - 0121 371 4242

Condition

Specialty: Injuries and emergencies, Primary sub-specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Burns and corrosions of multiple and unspecified body regions

Intervention

Patients are admitted to QEHB following a burn injury, those with a burn between 1-<10% TBSA (Total Body Surface Area) that is colonised with a bacteria and who meet the eligibility criteria are provided with details of the study along with a Patient Information Sheet. If they provide fully informed written consent they are then enrolled onto the study and randomised to receive treatment of the burn wounds via dressings soaked in either 0.5% of 2% acetic acid solution. The trial is double-blinded hence neither the treating clinical team or the participants know which concentration of acetic acid they have been randomised to.

Once on the trial the participants undergo twice daily dressing changes for a period of five days (except on day threewhen only one dressing change will take place). There is a total of nine dressing changes throughout the study period, which are equivalent to standard-of-care for these patients. The duration of the study also fall under the patient's standard-of-care. At each dressing change patients are asked to complete a Visual Analogue Scale (VAS) at four time-points to record their pain experience prior to analgesia, post burn wound cleaning and prior to treatment, immediately post treatment and 30 minutes post treatment. The dressings removed from patients containing wound exudate are then sent to the microbiology laboratory for further testing and examination. The burn wound surface pH are also measured during each dressing change as this there is evidence to suggest that wound surface pH correlates to the time of healing. Once daily (during the morning dressing change) participants also have a microbiology wound swab taken from their burn wounds. Participants are followed up at day 21 post burn injury, which fall in line with their standard of care hence participants have not have to attend this solely for trial-specific purposes.

Intervention type

Other

Phase

Phase II

Drug names

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 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

Overall trial start date

01/02/2017

Overall trial end date

01/08/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant 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

Recruitment start date

01/02/2018

Recruitment end date

01/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
University Hospitals Birmingham NHS Foundation Trust Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust

Sponsor details

Trust Hq
Po Box 9551
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in June 2019.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

30/06/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes