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Preparation designed to fit into your workflow

StrataGraft® is cryopreserved to deliver viable cells. Preparation should take approximately 20 minutes, and once prepared, StrataGraft can be held for up to 4 hours1

How StrataGraft is supplied:

StrataGraft

StrataGraft

Laminated foil pouch containing the Product Dish, which holds StrataGraft

  • Storage: -70°C to -90°C (-94°F to -130°F) or on dry ice during transport, storage, and transfer to the OR until ready to thaw
  • Components: StrataGraft (aseptic handling required)
  • Nonsterile components: Foil pouch, Product Dish

Hold Dish

Hold Dish

Clear pouch containing the Hold Dish

  • Storage: Room temperature
  • Sterile components: Identical top and bottom portions of Hold Dish
  • Nonsterile component: Clear pouch

Hold Solution

Hold Solution

1 bottle of Hold Solution inside a laminated foil pouch

  • Storage: Refrigerate between 2°C and 8°C (36°F and 46°F)
  • Components: Solution (aseptic handling required)
  • Nonsterile components: Pouch and bottle

StrataGraft integrates into your current workflow

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
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.

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).

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021. 3. Holmes JH IV, Schurr MJ, King BT, et al. An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. Burns. 2019;45(8):1749-1758. 4. Centanni JM, Straseski JA, Wicks A, et al. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Ann Surg. 2011;253(4):672-683. 5. Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866-874. 6. Holmes JH IV, Shupp JW, Smith D, et al. Preliminary analysis of a phase 3, open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partial-thickness thermal burns. Poster presented at: American Burn Association 52nd Annual Meeting; June 15-August 31, 2020.

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021. 3. Holmes JH IV, Schurr MJ, King BT, et al. An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. Burns. 2019;45(8):1749-1758. 4. Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866-874. 5. Holmes JH IV, Shupp JW, Smith D, et al. Preliminary analysis of a phase 3, open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partial-thickness thermal burns. Poster presented at: American Burn Association 52nd Annual Meeting; June 15-August 31, 2020. 6. van de Kar AL, Corion LU, Smeulders MJ, et al. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005;116(2):514-522.

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021.

Reference: 1. StrataGraft. Package insert. Stratatech Corporation; 2021.

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.

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).

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021. 3. Holmes JH IV, Schurr MJ, King BT, et al. An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. Burns. 2019;45(8):1749-1758. 4. Centanni JM, Straseski JA, Wicks A, et al. StrataGraft skin substitute is well-tolerated and is not acutely immunogenic in patients with traumatic wounds: results from a prospective, randomized, controlled dose escalation trial. Ann Surg. 2011;253(4):672-683. 5. Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866-874. 6. Holmes JH IV, Shupp JW, Smith D, et al. Preliminary analysis of a phase 3, open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partial-thickness thermal burns. Poster presented at: American Burn Association 52nd Annual Meeting; June 15-August 31, 2020.

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021. 3. Holmes JH IV, Schurr MJ, King BT, et al. An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. Burns. 2019;45(8):1749-1758. 4. Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009;66(3):866-874. 5. Holmes JH IV, Shupp JW, Smith D, et al. Preliminary analysis of a phase 3, open-label, controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative skin construct in patients with deep partial-thickness thermal burns. Poster presented at: American Burn Association 52nd Annual Meeting; June 15-August 31, 2020. 6. van de Kar AL, Corion LU, Smeulders MJ, et al. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005;116(2):514-522.

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Gibson ALF, Holmes JH IV, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns. Burns. 2021;47(5):1024-1037. doi:10.1016/j.burns.2021.04.021.

Reference: 1. StrataGraft. Package insert. Stratatech Corporation; 2021.