Cellutome Epidermal Harvesting System and In Vivo Reflectance Confocal Microscopy as a Novel Wound Healing Assessment Protocol

The document presents a novel wound healing assessment protocol combining the Cellutome™ epidermal harvesting system and in vivo reflectance confocal microscopy (RCM) to evaluate wound healing at the cellular level. This method was tested on four patients with different types of epidermolysis bullosa (EB) enrolled in an FDA trial (NCT02793960). The Cellutome™ system created uniform subepidermal wounds, and RCM provided non-invasive, cellular-level resolution of the skin's response to wounding and topical treatments. The study found significant differences in the degree of inflammatory infiltrate and the quality and organization of collagen fibers and fibroblasts in the wound base between week 1 and week 8. No blisters developed during or after the procedures, indicating the safety and utility of this combined approach as a reproducible standard for assessing wound healing in clinical studies.