A Prospective Randomised Clinical Study Comparing Polygalacturonic and Caprylic Acid Ointment to Medical‐Grade Honey in the Management of Chronic Wounds

ABSTRACT

The aim in this human trial is to compare the efficacy and safety of polygalacturonic–caprylic acid (PG–CAP) ointment to MediHoney in chronic wounds at three international medical centres. In this prospective open-label study, patients with chronic full-thickness wounds were randomised to daily treatment with PG–CAP ointment or MediHoney. Assessments were obtained weekly for 6 weeks. The validated Pressure Ulcer Scale for Healing (PUSH) score was used to track healing. Efficacies were compared using the Wilcoxon rank-sum test for continuous variables and chi-square or Fisher's exact test for categorical variables. Twenty-six patients with chronic wounds were included. Baseline characteristics were comparable between the groups; however, the history of diabetes mellitus was higher in the PG–CAP group (p = 0.011). All 13 PG–CAP patients showed improvement (100%), compared to only 69% of the 13 MediHoney patients (p = 0.023). Half of the failures in the MediHoney arm were associated with death (15%). No failures, adverse events or deaths occurred in the PG–CAP arm. PG–CAP wound ointment is a novel combination of two plant-based compounds that pose minimal risk of promoting antimicrobial resistance, was highly effective for eradicating wound-pathogen biofilms in vitro and promoted chronic wound healing in vivo with minimal inflammatory reactions. Our findings support PG–CAP as safe, noninferior and possibly more effective than MediHoney in healing chronic contaminated wounds.