Accelerating the aesthetic benefit of wound healing by triterpene

Abstract

Intention of the study (EudraCT No 2009-017418-56) is a proof of aesthetic benefit of triterpene treatment in superficial wounds. In an open, prospective, controlled, randomized, blindly evaluated multicentre phase II clinical trial a triterpene ointment (OG-S10) is compared intra individually with a state-of-the-art moist wound healing dressing (Mepilex(®)) in split thickness skin graft donor sites. The graft wound areas at the upper leg were divided into two equal halves, one proximal and one distal site. Decided by randomization the one site was treated with triterpene and the other in comparison with moist dressing. Triterpene treatment went on for 14 days as covering the wound at every change of wound dressing with the ointment (100 mg/cm(2)). The comparative treatment went on as covering the site by this dressing alone. The outcome of these different treatments was evaluated by two blindly observing distant experts on the basis of photographs of the wound healing progress. Photographs were taken day 14, 3 month and 1 year after treatment. The only criterion for evaluation of the two sites was similarity of the wound area to the surrounding skin in terms of colour and texture: which of the two sites, the proximal or the distal, was aesthetically superior in normal skin appearance after 14 days at the end of treatment, after 3 month of follow up and 1 year after treatment? The descriptive comparison is demonstrating quite a remarkable advantage of the ointment versus the moist wound dressing in promoting wound healing: even having in mind the small number of 24 patients within the protocol, the superiority of aesthetic benefit by triterpene treatment after 14 days (22 out of 24 patients), after 3 month (15 out of 19 patients) and after 1 year (8 out of 10 patients) is obvious.