AceticA
Research type
Research Study
Full title
A pilot randomised controlled trial to examine the efficacy and optimal dose of Acetic Acid to treat colonised burns wounds.
IRAS ID
234132
Contact name
Naiem Moiemen
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Eudract number
2017-003481-28
ISRCTN Number
ISRCTN11636684
Clinicaltrials.gov Identifier
XX2003, CAS Number (Internal)
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
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. Samples of the burns dressings will also be collected and analysed to see if the two strengths of acetic acid demonstrate any difference in the effects they have on the bacteria. If the lower concentration is shown to have similar effects in combating the bacterial infection and appear to be more tolerable for patients, this may lead to larger studies to investigate further.
Summary of Results
Abstract Purpose of the study: To investigate the tolerability and efficacy of 0.5% and 2% of acetic acid when applied to colonised burns wounds for 3 days after admittance to the Queen Elizabeth Hospital Birmingham.
People taking part: Patients aged ≥16 years old who consented to take part in the clinical study that were treated within the Burns Centre at Queen Elizabeth Hospital Birmingham for burn wounds with meet the inclusion/exclusion criteria of the study.
Results: Between 20-Feb-2018 and 08-Oct-2021, 22 participants were randomised. Baseline patient characteristics were generally balanced across both treatment arms although the total percentage of full thickness burns was lower in those patients who received 2.0% AA. 2.0% AA demonstrated a significant increase in the antibacterial efficacy compared to 0.5% (p = 0.0129). Only one serious adverse event was reported; grade 3 urinary tract infection, unrelated to Acetic acid, which resolved with no sequalae.
Safety: This phase 2 clinical trial study found that both concentrations of Acetic acid (0.5% W/V and 2% W/V) was safe to use in the treatment of patients and who had infection burn wounds.
Who Sponsored this study?
This study was sponsored by the University Hospitals Birmingham NHS Foundation Trust (UHBFT) . The Acetica trials office can be contacted via ACETICA@trials.bham.ac.uk.General information about the trial
The study took place in the United Kingdom only. Recruitment began in Feb/2018 and ended in Oct 2021. The treatment period was for 3 days (dressing changed twice each day except on day 3 (3 day treatment). Over the 3 days a total of 5 dressing will be applied). 22 patients were randomised into the study. 18 patients were considered to be evaluable. First patient recruited 20-feb-2018, Last patient recruited 08-Oct-2021. 22 Patient were recruited to the study (11 allocated to 0.5% Acetic acid, 11 allocated to 2.5 % Acetic Acid).The main objective of the study was to test the safety and tolerability of two concentrations of acetic acid (0.5% w/v & 2.0% w/v) for the treatment of infected burn wounds
Primary Outcome Measure:
1. Efficacy will be assessed by measuring the bacterial load from microbiology wound swabs, these will be taken daily from recruitment for 3 consecutive days.Secondary Outcome Measures:
1. The antimicrobial activity of acetic acid will be 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. Tolerance will be assessed by measuring a patient’s pain scores with a Visual Analogue Scale (VAS) if the patient has capacity to provide scores.
3. Time to 95% wound healing of the treated area of interest.
4. Perceived treatment allocation, assessed by asking patients after treatment completion which treatment they believed they received if they have capacity to do so.What patients were included in this study?
This trial included adult patients who attended the burns centre at the Queen Elizabeth Hospital – Birmingham, United Kingdom and who consented to take part in the study. The clinical team and study patients were blinded to the study of the intervention (actual concentration of the acetic acid) The study was split into 2 treatment groups of patients. The age range of the evaluable for patients (N=18) in the trial was Male (10), Female (8) (age range: 21-79) . 2 out of the 22 patients randomised withdraw consent part way though the study treatment. The reason for withdrawal of both patients related to the pain experienced during wound dressing changes. For patients treated under protocol versions 1.0-4.0, 6 out of 9 dressing changes were required for a patient to be considered evaluable.
Which medicine was studied?
All patients received the study drug (Acetic acid) alongside standard-of-care., Acetic acid was applied to the wounds by pre-soaking cotton-gauze dressing immediately prior to application and applying directly to the wound. This dressing was then covered by a layer of dry gauze.What were the side effects?
Serious Adverse Events (SAEs) were reported from the date of consent until the third dressing had been removed (Day 4). SAEs include untoward medical occurrences that result in patients having unplanned hospital submission or prolongation of hospital admission, are life threatening, result in death, cause long term or significant disability or incapacity or cause birth defects or otherwise considered of medical importance by the investigator.
During the trial there were no reported deaths. 1 serious adverse event was reported – unrelated to study medication
10 AEs were reported in 5 distinct patients during the ACETICA trial. No adverse event had a frequency of greater than 1 when grouped according to allocated treatment What were the overall results of the study?
It was concluded that both concentration of Acetic acid used in the study were both safe and tolerable. 2.0% W/V acetic acid was found to have efficacy related to the control of infections with the burn wound and therefore will be the concentration that is to used / recommend for clinical evaluation in future studies that involve this interventionHow has this study helped patients and researchers?
The primary aim of the study was safety, associated with tolerability and safety outcome measures. The study provided additional safety information associated with the administration of the acetic acid and will inform future studies and medical care that involve the use of acetic acid to treat and control infection in burn wounds and other wounds to the skin.
The final analysis for this study was completed July/2023.Are there plans for further studies?
At present, there are further studies being planned by the University Hospitals Birmingham NHS foundation Trust 9in collaboration with other partners which involve 2% Acetic Acid (w/v).Where can I find more information about this study?
To learn about this study, you can find more detailed information on the EU database.
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Ftrial%252F2017-003481-28%252FGB.%2FNBTI%2FIvK5AQ%2FAQ%2Fcb2932ec-ea05-45cb-bc30-e7e88906894a%2F2%2FdqCX8rmEqj&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C52e12e403bcd4da318a008dd19d05ef6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638695104927647308%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=f1M%2FzJVeyWdzVgthRHhr43OB70lCLJ16T3C1tIVBRpU%3D&reserved=0The trial protocol has been published in the BMJ open: Imran R, Hassouna T, Sur G, et al. Efficacy andoptimal dose of acetic acid to treat colonised burns wounds: protocol for a pilot randomised controlled trial. BMJ Open 2023;13:e058006. doi:10.1136/
bmjopen-2021-058006: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fbmjopen.bmj.com%252Fcontent%252F13%252F9%252Fe058006%2FNBTI%2FIvK5AQ%2FAQ%2Fcb2932ec-ea05-45cb-bc30-e7e88906894a%2F1%2F5Eis3TKYnT&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C52e12e403bcd4da318a008dd19d05ef6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638695104927666855%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=KIz%2FDovm%2Bavdf5pE0SPOydlqOCLbthufPGPouFgAEtw%3D&reserved=0The trial results have been published: submitted for publication – awaiting outcome
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0407
Date of REC Opinion
21 Dec 2017
REC opinion
Further Information Favourable Opinion