The trial included 175 patients at 25 medical centers around the world. The patients were divided into two groups, one which received Debrase, and the control group which received standard treatment.
The final analysis of the trial found statistically significant success in the trial's two primary endpoints. Debrase reduced the number of patients who required surgery to remove burned tissue. In addition, the number of patients who required skin transplant surgery over the burned area was also reduced.
MediWound also reported statistically significant success in the trial's secondary endpoints. These included shorter treatment time to heal the burned tissue, and reduction in blood loss involved in removal of the burned tissue without disturbance to the closing of the burned area, compared with current treatments.
On the basis of the trial results, MediWound intends to submit a marketing application for Debrase with the European Medicines Agency (EMA) later this year. The company estimates that approval will take about a year.
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