OLEOGEL-S10 TO ACCELERATE HEALING OF DONOR SITES: MONOCENTRIC RESULTS OF PHASE III CLINICAL TRIAL.

MATERIAL AND METHODS: Oleogel-S10, an ointment containing betulin-rich triterpene dry extract from birch bark was tested in an open, blindly evaluated, prospective, controlled, randomized multicentre study to improve wound healing in donor sites. The primary endpoint was time to wound closure, and secondary endpoints were scar related measurements at the time of wound closure, and 3 and 12 months after wound closure (POSAS, laser speckle contrast analysis, viscoelastic analysis). RESULTS: We report the results from a single centre (Department of Burns and Reconstructive Surgery, University Hospital Brno) of this phase III clinical trial. A total of 32 patients (25 men and 7 women) were included with the mean patient age of 41.8 years (SD, ±11.66). The mean extent of patients donor sites in the study was 56.77cm2 (SD, ±20.39). Median healing time of the verum group (Oleogel-S10) was 7 days (95% Confidence Interval 7-8 days) and for controls 8 days (95% CI 7-10 days). Comparison of POSAS data from the verum group revealed significantly lower values at all three time points as compared to the controls. Perfusion of scars of the verum group reached on average of 115 perfusion units at the end of treatment; the average was 69.8 perfusion units at the 3-month follow-up and 50.2 perfusion units at the 12-month follow-up. Control sites displayed significantly higher values at all time points (122.2 perfusion units, 73.9 perfusion units, 52.2 perfusion units). Significant differences were detected in the skins viscoelastic properties, with sites treated with Oleogel-S10 displaying more favourable values. CONCLUSION: In our results, we demonstrate the significant effectiveness of Oleogel-S10 in donor sites healingKeywords: Donor site, Triterpenes, Oleogel-S10, wound closure.

Light-emitting diode irradiation promotes donor site wound healing of the free gingival graft.

BACKGROUND: This study aims to evaluate the effect of light-emitting diode (LED) light irradiation on the donor wound site of the free gingival graft. METHODS: Rat gingival fibroblasts were chosen to assess the cellular activities and in vitro wound healing with 0 to 20 J/cm(2) LED light irradiation. Seventy-two Sprague-Dawley rats received daily 0, 10 (low-dose [LD]), or 20 (high-dose [HD]) J/cm(2) LED light irradiation on the opened palatal wound and were euthanized after 4 to 28 days; the healing pattern was assessed by histology, histochemistry for collagen deposition, and immunohistochemistry for tumor necrosis factor (TNF)-α infiltration. The wound mRNA levels of heme oxygenase-1 (HO-1), TNF-α, the receptor for advanced glycation end products, vascular endothelial growth factor, periostin, Type I collagen, and fibronectin were also evaluated. RESULTS: Cellular viability and wound closure were significantly promoted, and cytotoxicity was inhibited significantly using 5 J/cm(2) LED light irradiation in vitro. The wound closure, reepithelialization, and collagen deposition were accelerated, and sequestrum formation and inflammatory cell and TNF-α infiltration were significantly reduced in the LD group. HO-1 and TNF-α were significantly upregulated in the HD group, and most of the repair-associated genes were significantly upregulated in both the LD and HD groups at day 7. Persistent RAGE upregulation was noted in both the LD and HD groups until day 14. CONCLUSION: LED light irradiation at 660 nm accelerated palatal wound healing, potentially via reducing reactive oxygen species production, facilitating angiogenesis, and promoting provisional matrix and wound reorganization.