title: Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions.
abstract: The acceleration of wound healing is a major surgical concern. A triterpene extract from birch bark (Betulae cortex) experimentally enhances keratinocyte differentiation in vitro and accelerates wound healing ex vivo. We conducted an open, blind-evaluated, controlled, prospective, randomized (1:1) phase II clinical trial in patients requiring split-thickness skin graft transplantation at two university hospitals in Germany. Donor sites on the upper legs were covered with a moist silicone-coated dressing. Oleogel-S10 ointment containing 10% birch bark extract was randomly applied to the distal or proximal half of the wound, with the other half serving as an intraindividual control, for 14 days after the skin graft surgery. The primary efficacy variable was faster reepithelialization as determined from macrophotographs by independent, blinded experts. Twenty-four patients were randomized and completed the trial. After the 14-day test period, the planned interim analysis revealed a highly significant (p < 0.0001) superiority of Oleogel-S10 in the primary efficacy variable and the trial was terminated early due to ethical concerns. The treatment side was also better reepithelialized and more similar to normal skin after 3 months. In conclusion, Oleogel-S10 significantly accelerated reepithelialization at split-thickness skin graft donor sites. Treatment with Oleogel-S10 was safe and well tolerated.
authors.affiliation: Department of Oral and Maxillofacial Surgery/Plastic Surgery, Medical School, Greifswald University, Greifswald, Germany.
authors.forename: Hans-Robert
authors.initials: HR
authors.lastname: Metelmann
authors.forename: Johanna M
authors.initials: JM
authors.lastname: Brandner
authors.forename: Hauke
authors.initials: H
authors.lastname: Schumann
authors.forename: Felix
authors.initials: F
authors.lastname: Bross
authors.forename: Rolf
authors.initials: R
authors.lastname: Fimmers
authors.forename: Kerstin
authors.initials: K
authors.lastname: Böttger
authors.forename: Armin
authors.initials: A
authors.lastname: Scheffler
authors.forename: Fred
authors.initials: F
authors.lastname: Podmelle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D029662:Betula; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D024301:Plant Bark; D010936:Plant Extracts / Q000627:therapeutic use*; D010938:Plant Oils / Q000627:therapeutic use; D016037:Single-Blind Method; D016038:Skin Transplantation; D000074242:Sunflower Oil; D014315:Triterpenes / Q000627:therapeutic use*; D014945:Wound Healing / Q000187:drug effects*; D055815:Young Adult
chemical_list: D010936:Plant Extracts; D010938:Plant Oils; D000074242:Sunflower Oil; D014315:Triterpenes