Efficacy and Optimal Dose of Acetic Acid for Treating Colonized Burns Wounds (AceticA): A Double-Blind, Single-Center, Randomized, Controlled Phase II Trial

Evaluate the effectiveness and tolerability of 0.5% and 2.0% (w/v) acetic acid on colonised burns wounds for three days after hospital admission. Burn wound infection and secondary sepsis are serious complications. Due to growing bacterial resistance worldwide, effective antimicrobial agents that do not increase the risk of resistance and are non-toxic are required. In this is phase II trial, 0.5% or 2.0% acetic acid was applied to burns colonised by specifically identifiable bacteria. Participants aged ≥16 years with burns ≥1% body surface area were randomly assigned 1:1. Efficacy was measure by change in bacterial load from swabs taken daily for four consecutive days. The study encountered two interruptions during the Covid-19 pandemic lockdown. Consequently, major protocol amendments were implemented to ensure alignment with established hospital clinical pathways. Between Feb-2018 and Oct-2021, 22 participants were randomized. Participant characteristics were balanced, except fewer full thickness burns in the 2.0% acetic acid group. Two percent acetic acid significantly decreased the bacterial load compared to 0.5% concentration (p=.0129) but also increased the pain score (p=.012). Only one serious adverse event occurred: a grade 3 urinary tract infection unrelated to acetic acid, which resolved without sequalae. Acetic acid was safe and well-tolerated. Both concentrations lowered bacterial load, with 2.0% proving more effective. The study also indicates that dressing changes every 12 hours may be required.