A Prospective Randomised Clinical Study Comparing Polygalacturonic and Caprylic Acid Ointment to Medical-Grade Honey...

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.