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Epicel (cultured epidermal autografts) is authorized 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%. It 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. The effectiveness of the device for this use has not been demonstrated.
Important Safety Information
Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds.
Assess for positioning, splinting, and need for specialty bed.
Monitor areas to be grafted with Epicel closely for infection.
Eliminate wound infection to produce a minimal/no growth wound bed.
Obtain wound cultures at least: One (1) week pregrafting and
One to two (1-2) days pre-grafting
Review culture results twice a day and treat infection immediately and aggressively.
Continue aggressive PT/OT prior to grafting.
Consider final wound bed prep 24-48 hours prior to Epicel grafting to achieve hemostasis.
Do not use chlorhexidine gluconate (CHG)/cytotoxic agents on or near body sites where Epicel grafts will be placed.
Plan for terminal clean of room and new bed day of grafting.
Stage 2: Immediate post-operative care until takedown
Avoid pressure and shearing of Epicel grafts.
Change outer layers of dressing daily to the bridal veil or more frequently if clinically indicated.
Drying of Epicel grafted areas is critical to support patient healing. Expose grafted areas to air at least 4 hours per day, preferably up to 12 hours, as tolerated.
Monitor Epicel grafted areas for signs of infection.
Obtain wound cultures p.r.n.
If topicals are applied, use the “wring-out” procedure, do not saturate.
Evaluate grafts at 3-5 days post-op to plan timing of takedown.
Do not use CHG/cytotoxic agents on or near body sites where Epicel grafts have been placed.
No PT/OT to areas grafted with Epicel until takedown.
Stage 3: Post-operative care after takedown
Apply non-adherent dressing (e.g. Adaptic® or Cuticerin™) directly over Epicel then apply outer gauze wrap and bulky dressings.
Change dressings daily.
Continue to expose grafted areas to air at least 4 hours per day, preferably up to 12 hours, as tolerated.
Monitor grafted areas and wound bed for signs or symptoms of infection.
Monitor daily for signs of infection (drainage or odor), continue wound cultures p.r.n.
If topicals are applied, use the “wring-out” procedure, do not saturate.
Gentle PT/OT may be initiated during dressing changes. Be careful with hand placement during range of motion (ROM) exercises.
Continue to avoid shearing forces.
Do not use CHG/cytotoxic agents on or near body sites where Epicel grafts have been placed.
Do not soak or scrub Epicel grafted areas.
Stage 4: Long term care after skin integrity is established
Wash with mild soap (gentle, non-irritating, non-perfumed). Avoid tub immersion and soaking to prevent skin maceration.
Moisturize with mild lotion or cream (water based preferred, non-perfumed, non-irritating).
Monitor and treat blisters conservatively in Epicel grafted areas; apply light dressing as indicated.
Apply pressure garments (per physician protocol) when wounds are closed.
Increase activity levels as patient tolerates.
Avoid sun exposure to grafted areas and apply sunscreen.
To order a Patient Care Resources kit for an Epicel patient, please contact your Vericel Account Manager or call 1-800-CEA-SKIN (1-800-232-7546)
The speakers presented in the below videos are paid consultants of Vericel Corporation.
Kari Gabehart, FNP-BC
discusses the importance
of pre-operative swabs
Cassie Rush, DPT explains pre-surgical range of motion
Cassie Rush, DPT on measuring range of motion
Kari Gabehart, FNP-BC post-op airing of Epicel
Kari Gabehart, FNP-BC begins takedown on an Epicel patient
Epicel (cultured epidermal autografts) is authorized 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%. It 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. The effectiveness of the device for this use has not been demonstrated.
Important Safety Information
Epicel is contraindicated in patients with a history of anaphylaxis following exposure to vancomycin, amikacin, and amphotericin, as trace quantities of these anti-infective agents may remain in the Epicel autograft. Epicel should not be used in patients with known sensitivities to materials of bovine or murine origin. It is contraindicated for use on clinically infected wounds.
Because Epicel is manufactured with and contains residual amounts of murine cells, FDA considers it a xenotransplantation product. Therefore, recipients should not donate whole blood, blood components, source plasma, source leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans because there is a potential risk of carrying an infection that is transmitted from mouse cells to humans.
Squamous cell carcinoma (SCC) has been reported in patients with burn injury after being grafted with Epicel. Although SCC is a known complication of burn scars, the role of Epicel in the causation of SCC cannot be excluded.
The Epicel product is intended solely for autologous use. Patients undergoing the surgical procedure associated with Epicel are not routinely tested for transmissible infectious diseases. Discontinue use if the patient shows evidence of allergic reaction.
If clinical signs of infection are present or develop, do not apply Epicel until the infection is adequately treated.
The effectiveness of Epicel has not been proven in clinical studies.
The long-term safety of Epicel is unknown. Over the past 27 years, the mortality from all causes was 13% before hospital discharge.
Men and women who intend to have children should be advised that the effects, if any, of Epicel on fetal development have not been assessed. In addition, the safety of Epicel has not been studied in pregnant and nursing women.
Patient information supplied by attending burn teams from 1989 to 1996 reported the adverse events of highest incidence as: death (13%), infection (13.8%), graft tear (7.8%) or graft blister (4.2%) and drainage (3.3%). Some of these events may have been due to the underlying burn injury and not the device itself.
From June 1998 through September 2015 adverse events received by Genzyme Biosurgery (predecessor in interest to Vericel) and Vericel Corporation were similar to the previously identified adverse events. Events that were reported in ≥ 1% of patients included multi-organ failure (6.6%), sepsis (5.2%) infection (4%) and skin graft failure/graft complication (2.7%). The relationship of these events to Epicel has not been established.
Hickerson WL, Remmers AE, Recker DP. Twenty-Five Years’ Experience and Beyond with Cultured Epidermal Autografts for Coverage of Large Burn Wounds in Adult and Pediatric Patients, 1989-2015. J Burn Care Res. 2019;40(20):157-165
American Burn Association National Burn Repository 2016 Report version 12:0:10
Mathew Varkey, Jie Ding, Edward E. Tredget. Advances in Skin Substitutes – Potential of Tissue Engineered Skin for Facilitating Anti-Fibrotic Healing. J. Funct. Biomater. 2015, 6, 547-563
Bishara S. Atiyeh, Michel Constagliola. Cultured epithelial autograft (CEA) in burn treatment: Three decades later. Burns, November 2006;40
Rajiv Sood, MD, David Roggy, RN, Madeline Zieger, PA-C, et. al Cultured Epithelial Autografts for Coverage of Large Burn Wounds in Eighty-Eight Patients: The Indiana University Experience, J Burn Care Res, 2010;31:559-568
Williams FN, Herndon DN, Jeschke MG. The hypermetabolic response to burn injury and interventions to modify this response. Clin Plast Surg. 2009 Oct;36(4):583-96
Cuono C, Langdon R, McGuire J. Use of cultured epidermal autografts and dermal allografts as skin replacement after burn injury. Lancet. 1986;1:1123-4
Rajiv Sood, MD, Beretta Craft-Coffman, PAC, Paula Fillari, RN, CCRN. Surgical Guidelines for Epicel® cultured epidermal autografts (CEA). 2015
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