A clinical trial looking at the efficacy and optimal dose of acetic acid in burn wound infections

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?
People aged 16 years 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 with dressings soaked in 0.5% acetic acid solution. Those in the second group have their burns treated with dressings soaked in 2% acetic acid solution. Participants undergo twice daily dressing changes for a period of 3 days (except on day 3 when only one dressing change will take place). There is a total of five dressing changes throughout the study period, which are equivalent to usual treatment for these patients. The duration of the study also falls under usual treatment. At each dressing change patients are asked to record their pain experience before pain relief, after burn wound cleaning and before treatment, immediately after treatment and 30 minutes after treatment. The dressings removed from patients containing wound fluid are then sent to the microbiology laboratory for further testing and examination. The burn wound surface pH (which shows how acidic the wound is) is also measured during each dressing change as this there is evidence to suggest that wound surface pH relates to the healing time. Once daily (during the morning dressing change) participants also have a microbiology wound swab taken from their burn wounds to investigate the levels and types of bacteria in their wound. The date that the wound is 95% healed will be recorded in the Prescribing Information and Communication System (PICS).

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 January 2022

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

Who is the main contact?
Miss Gurneet Sur, g.sur@bham.ac.uk

Study website

Type

Scientific

Contact name

Miss Gurneet Sur

ORCID ID

Contact details

D3B Clinical Trial Team
Cancer Research UK Clinical Trials Unit (CRCTU)
Open Plan East
Fifth Floor ITM
Heritage Building
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom
+44 (0)121 371 8459
g.sur@bham.ac.uk

EudraCT/CTIS number

2017-003481-28

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 36451

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(s)

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

Study design

Randomized; Interventional; Design type: Treatment, Other

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

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

Condition

Burn wound infections

Intervention

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 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 3 days (except on day 3 when only one dressing change will take place). There is a total of five dressing changes throughout the study period, which is 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. The date that the treated area has reached 95% healing will be collected as part of the trial data; this data can be retrospectively obtained from the Prescribing Information and Communication System (PICS) at the end of the trial.

_____

Previous intervention:
Patients are admitted to QEHB following a burn injury, those with a burn ≥1% 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 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 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

Primary outcome measure

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 outcome measures

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

Overall study start date

01/02/2017

Overall study end date

04/01/2022

Reason abandoned (if study stopped)

Participant 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

Participant type(s)

Patient

Age group

Adult

Lower age limit

16 Years

Sex

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Total final enrolment

22

Participant 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

Recruitment start date

01/02/2018

Recruitment end date

22/11/2021

Countries of recruitment

England, United Kingdom

Study participating centre

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

Organisation

University Hospitals Birmingham NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

ROR

https://ror.org/014ja3n03

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

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

Intention to publish date

04/01/2023

Individual participant data (IPD) sharing plan

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

IPD sharing plan summary

Other

Study outputs