SAEs
SAEs, colonization/infection
Nine SAEs occurred during the phase I and II trials and were reported to the Medical Ethics Committee of the district Noord-Holland in the Netherlands. All SAEs occurred in patients with acute burn wounds. One SAE concerned a patient who died before application of the investigational product. Of the eight remaining SAEs, five were related to the study areas and concerned slow wound healing, for which reoperation was deemed beneficial. Of these five, two patients experienced wound colonization/infection in which the dermal matrix area was reoperated, one patient was reoperated in the standard treatment area because of shearing forces in the wound area, and two patients were reoperated in both areas because of slow wound healing. The other three SAEs concerned a reoperation to stimulate wound healing in areas other than the study areas.