allogeneic cultured keratinocytes and fibroblasts (Rx)

>10%

Pruritus (11%)

1-10%

Blisters (4%)

Hypertrophic scar (3%)

Impaired healing (3%)

Contraindications

Known allergies to murine collagen or products containing ingredients of bovine or porcine origin

Cautions

Contains glycerin; avoid in patients with known sensitivity

Severe hypersensitivity reactions may occur; monitor for both early and late symptoms and signs following application; treat according to standard medical practice

Because this is a xenotransplantation product, recipients should not donate whole blood, blood components, plasma, leukocytes, tissues, breast milk, ova, sperm, or other body parts for use in humans

Transmission of infectious diseases

• Contains cells from human donors and may transmit infectious diseases or infectious agents, such as viruses, bacteria, or other pathogens, including the agent that causes transmissible spongiform encephalopathy (TSE, also known as Creutzfeldt-Jakob disease [CJD] or variant CJD)
• Classified as a xenotransplantation product because of historic exposure of the keratinocyte cells to well-characterized mouse cells
• Cell banks have been tested and found to be free of detectable adventitious agents, and mouse cells are no longer used in the manufacture of StrataGraft; however, these measures do not entirely eliminate risk of transmitting infectious diseases and disease agents
• Transmission of infectious diseases or agents has not been reported

Drug interaction overview

• Mafenide

  • Not recommended
  • Mafenide acetate, a topical antimicrobial, reduces keratinocyte viability and disrupts integrity of tissue-engineered human skin substitutes composed of keratinocytes

• Silver-containing antimicrobials and dressings

  • Not recommended
  • Data suggest silver may decrease viability of keratinocytes and human dermal fibroblasts

• Chlorhexidine

  • Not recommended
  • Chlorhexidine topical antiseptic shown to be toxic to keratinocytes and human dermal fibroblasts

Pregnancy

There are no available data regarding use in pregnant females

No animal reproductive and developmental toxicity studies have been conducted to assess whether it can cause fetal harm

Lactation

Data are unavailable on presence in human milk, effect on breastfed infants, or effect on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Allogeneic cellularized scaffold product containing metabolically active cells that produce and secrete a variety of growth factors and cytokines

Growth factors, cytokines, and extracellular matrix proteins are known to be involved in wound repair and regeneration

Does not remain permanently engrafted, but is replaced by the patient’s own cells over time, eliminating or reducing the need for autografting to attain definitive closure of the majority of treated wounds

Preparation

Following wound bed preparation (excision/debridement), determine number of constructs that need to be thawed

Two operators (a sterile operator and a nonsterile operator) are required for the procedures

Follow instructions and diagrams provided in Prescribing Information

Topical Application

Apply in appropriate aseptic conditions by a trained healthcare provider

Follow the steps below for topical application

• If using fibrin glue to anchor constructs, apply before placing the meshed construct on the prepared wound bed; if using anchoring methods other than fibrin glue, start with next step
• Place the meshed StrataGraft with the dermal (shiny) side down in contact with prepared wound bed; ensure epidermal (matte) side is facing up; abut constructs when placing multiple constructs; overlapping edges is not required

• Note

  • If treated area is smaller than 1 construct, trim excess before or after anchoring to the wound bed
  • Ensure construct has contact across entire surface of the wound bed
  • Do not stretch or expand construct; doing so may degrade structural integrity
• Anchor construct with staples, tissue adhesive (eg, cyanoacrylate), or sutures to keep from dislodging; place porous, nonadherent contact dressing over construct and leave dressing in place for 1 week before changing
• Place second layer of dressing that does not contain silver
• Placement of an outer bolster or wrap that keeps from moving as clinically appropriate is at the discretion of the physician

Storage

Constructs: Freeze between -70ºC and -90ºC (-94ºF to -130ºF)

Hold solution: Refrigerate at 2-8ºC (36-46ºF)

Hold dishes: Store at ambient temperatures

Do not use any of the above components if they have been compromised

Dispose of unused constructs as surgical biohazardous waste in accordance with local requirements

Dispose of materials that have come into contact with constructs as surgical biohazardous waste in accordance with local requirements