Mallinckrodt Pharmaceuticals StrataGraft®

(allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat)

StrataGraft®

(allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat)

Sorry we missed you at the Southern Region Burn Conference StrataGraft interactive hands-on educational symposium.

Join us next time at the American Burn Association Annual Meeting

Touch, Handle, Experience StrataGraft®

Learn from Experts
Clinical Cases, Wound Healing Progression, Post Op Management

Ask Questions & Interact with Colleagues

When: ABA Annual Meeting

Who: US-based healthcare providers caring for burn patients (Not CME-Eligible)


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INDICATION
StrataGraft ® is an allogeneic cellularized scaffold product indicated for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
IMPORTANT SAFETY INFORMATION
Contraindications
  • Do not use in patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin.
Warnings and Precautions
  • StrataGraft contains glycerin. Avoid glycerin in patients with known sensitivity (irritant reaction) to glycerin.
  • Severe hypersensitivity reactions may occur. Monitor for both early and late symptoms and signs of hypersensitivity reaction following StrataGraft application, and treat according to standard medical practice.
  • StrataGraft contains cells from human donors and may transmit infectious diseases or infectious agents, eg, viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD or variant CJD]).
  • StrataGraft is a xenotransplantation product because of an historic exposure of the keratinocyte cells to well-characterized mouse cells. The cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are not used in the manufacture of StrataGraft; however, these measures do not entirely eliminate the risk of transmitting infectious diseases and disease agents.
  • Transmission of infectious diseases or agents by StrataGraft has not been reported.
  • Because StrataGraft is a xenotransplantation product, StrataGraft recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans.
Adverse Reactions
  • The most common adverse reactions (incidence ≥2%) were itching (pruritus), blisters, hypertrophic scar, and impaired healing. Other adverse events reported are included in the full Prescribing Information.
Pediatric Use
  • The safety and effectiveness of StrataGraft in pediatric patients (<18 years) have not been established.
Please see full Prescribing Information.