Epicel® cultured epidermal autografts (CEA) is an aseptically processed wound dressing composed of autologous keratinocytes grown ex vivo in the presence of proliferation-arrested mouse fibroblasts for treating deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30%. Epicel® consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel® is attached to petrolatum gauze backing with stainless steel surgical clips and measures approximately 50 cm2 in area.
In a 7-year study, the survival rate of patients treated with the CEA in addition to standard care was significantly higher compared to controls treated with standard care only.
EPICEL is approved by the FDA for use as a humanitarian-use device (HUD). Namely, effectiveness of EPICEL has not been proven in clinical studies.
Epicel® should not be used in patients with a known history of anaphylaxis to vancomycin and amikacin. Epicel® should not be used in patients with known sensitivities to materials of bovine or murine origin.
Death (9%), sepsis (3.7%), multi-organ failure (3.3%) and skin graft failure/graft complication (1.3%). The relationship of these events to EPICEL® has not been established.