Efficacy and optimal dose of acetic acid for treating colonised burns wounds (AceticA): a double-blind, single Centre, randomised, controlled phase II trial

Evaluate the effectiveness and tolerability of 0.5% and 2.0% (w/v) acetic acid on colonized burns wounds for 3 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 phase II trial, 0.5% or 2.0% acetic acid was applied to burns colonized by specifically identifiable bacteria. Participants aged ≥ 16 years with burns ≥ 1% BSA were randomly assigned 1:1. Efficacy was measured by change in bacterial load from swabs taken daily for 4 consecutive days. The study encountered 2 interruptions during the COVID-19 pandemic lockdown. Consequently, major protocol amendments were implemented to ensure alignment with established hospital clinical pathways. Between February 2018 and October 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 sequelae. 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 h may be required.

Clinical trial registration: EudraCT: 2017-003481-28. ISRCTN 11636684.