Wound healing characteristics of a novel wound healing ointment in an abrasive wound model: A randomised, intra-individual clinical investigation

Abstract

Moist wound healing conditions are beneficial in a professional wound care setting as well as for self-treatment of acute, superficial wounds. The purpose of this randomized, controlled, investigator-blinded investigation was to determine the local tolerability, wound healing efficacy and cosmetic outcome of a novel wound healing ointment in an intra-individual comparison of 4 treatment regimens in an abrasive wound model. Standardized abrasive wounds were induced on the inner forearms of 30 healthy subjects and 4 treatment regimens were randomly allocated to test areas (wound healing ointment covered with standard first aid dressing, wound healing ointment covered with gauze, standard first aid dressing alone, untreated area covered with gauze). Wounds were treated once daily for 11 days. Local tolerability and wound healing were assessed using visual scoring and digital photography on 5 different days. The cosmetic outcome was evaluated on a follow-up visit on Day 31. The wound healing ointment exhibited excellent local tolerability with superior assessments in comparison to treatment utilizing only dressings without ointment. Significant differences between AUC values for re-epithelization and overall wound healing efficacy were demonstrated in favor of treatment with the wound healing ointment in comparison to dry wound healing conditions. Wounds treated with the wound healing ointment showed a faster onset of healing and the cosmetic outcome was rated as being superior for the wound healing ointment both by the investigator and the subject. Superficial cutaneous wounds treated with the novel wound healing ointment displayed a significant improvement of wound healing with an earlier onset of re-epithelization, faster wound closure and a better cosmetic outcome. Clinically relevant accelerated wound healing compared to traditional dry healing could be shown demonstrating the benefits of moist wound healing conditions also in the treatment of minor, superficial wounds (Clinical trial identification number: EUDAMED_CIV 17-04-019364).