Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. 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 titanium surgical clips and measures a minimum of 50 cm2 in area.Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
A non-sterile tissue, in vitro cultivated from cells of human and animal origin, intended to cover skin wounds typically resulting from a burn injury. It is developed by ex vivo aseptic processing of a biopsy of skin from the recipient, involving enzymatic digestion and multiplication (culture) of epidermal cells combined with proliferation-arrested, murine (mouse) fibroblasts, to produce a graft of sufficient size for wound coverage. It is typically supplied by attachment to a gauze backing and may be used alone or in conjunction with split-thickness skin autografts.
Do not store in a refrigerator or freezer. Do not refrigerate, freeze, or incubate the Epicel shipping container or its contents. Do not reuse, freeze, refrigerate, or sterilize Epicel after opening.
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Inspect the Epicel packaging and ensure that it is intact. Do not use Epicel if package is opened or damaged.
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Inspect the medium in which Epicel is transported. Do not use an Epicel graft if the medium appears cloudy, or the graft dish has a broken seal or appears cloudy..
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Inspect the self-seal bags that contain Epicel grafts for media leaks. If a self-seal bag contains media, then inspect each graft dish in the bag for broken seal or damage prior to use.
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Keep Epicel out of the operating room until ready for application
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Maintain the shipping carton closed and at cool room temperature (13 to 23°C, 55 to 73°F).
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Store Epicel in the original shipping container in which it is received. Do not remove from original shipping container until ready for use.
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