Efficacy and optimal dose of acetic acid to treat colonised burns wounds: protocol for a pilot randomised controlled trial

INTRODUCTION: Despite of recent advancement in the burns wound management, burn wound infection (BWI) is still one of the major cause of burns mortality. Patients who survive their burns injury still suffers from BWI related complication like delayed wound healing and poor scarring. BWI has been treated by application of topical antimicrobial agents or systemic antibiotics. Due to the global risk of developing systemic antibiotics resistance, medical research focuses on identifying single topical agent which has effective antimicrobial activity, easily available and cost effective. One such agent is acetic acid (AA). AA has been used as a topical antibacterial agent for the treatment of burns wounds for many years and has shown to have activity against gram-negative organisms including Pseudomonas aeruginosa. So far there has been no consensus on optimal concentration that has effective antimicrobial activity, frequency of application, duration of treatment and most importantly good patient’s tolerability. A randomised control study is required to answer all these questions. OBJECTIVE: To investigate the efficacy and tolerability of 0.5% and 2% of AA when applied to colonised burns wounds for 3 days after admittance to the Queen Elizabeth Hospital Birmingham. METHODS AND ANALYSIS: This is a double-blinded, prospective, randomised, controlled, single-centre trial. Patients will be screened for eligibility in the inpatient area and those who are found to be eligible will be randomly assigned to one of two treatment groups: group 1: 0.5% AA (10 patients); group 2: 2% AA (10 patients); total number: 20 patients. OUTCOME MEASURES: Primary outcome: Efficacy will be assessed by measuring the bacterial load from microbiology wound swabs for three consecutive days. Secondary outcomes: (1) The assessment of antimicrobial activity of AA and the minimum inhibitory concentrations. (2) Patient’s tolerance by assessing Visual Analogue Scale pain score. (3) Time to 95% wound healing of treatment area. (4) Patient’s perceived treatment allocation. ETHICS AND DISSEMINATION: AceticA trial protocol was approved by the National Research Ethics Service (West Midlands—Edgbaston Research Ethics Committee; 17/WM/0407; IRAS 234132). This article refers to protocol version 5.0 dated 6 July 2020. The analysed results will be presented at national and international conferences related to management of burn patients. The generated articles based on the trial results will be submitted to peer review journals for publication. TRIAL REGISTRATION NUMBER: ISRCTN11636684.