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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 AND INDICATION
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. Mallinckrodt announces US FDA approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat). Mallinckrodt Pharmaceuticals. Published June 15, 2021. https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Mallinckrodt announces US FDA approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat). Mallinckrodt Pharmaceuticals. Published June 15, 2021. https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic 3. 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 4. 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. doi:10.1016/j.burns.2019.07.021 5. 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. doi:10.1097/SLA.0b013e318210f3bd 6. 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. doi:10.1097/TA.0b013e31819849d6

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. doi:10.1016/j.burns.2019.07.021 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. doi:10.1097/TA.0b013e31819849d6 5. 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. doi:10.1097/01.prs.0000172982.43599.d6

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. Mallinckrodt announces US FDA approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat). Mallinckrodt Pharmaceuticals. Published June 15, 2021. https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic

References: 1. StrataGraft. Package insert. Stratatech Corporation; 2021. 2. Mallinckrodt announces US FDA approval of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat). Mallinckrodt Pharmaceuticals. Published June 15, 2021. https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic 3. 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 4. 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. doi:10.1016/j.burns.2019.07.021 5. 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. doi:10.1097/SLA.0b013e318210f3bd 6. 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. doi:10.1097/TA.0b013e31819849d6

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. doi:10.1016/j.burns.2019.07.021 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. doi:10.1097/TA.0b013e31819849d6 5. 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. doi:10.1097/01.prs.0000172982.43599.d6

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.

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StrataGraft phase 3 study design

Seventy-one adult patients aged 19 to 79 who sustained 3% to 37% TBSA thermal burns on the torso, arms, or legs were enrolled in the phase 3 clinical trial. In each patient, 2 DPT areas of comparable depth were randomized to either cryopreserved StrataGraft or autograft.1,21,3

The anatomic treatment sites for StrataGraft included upper extremities (n=31; 43.7%), lower extremities (n=25; 35.2%), and trunk (n=15; 21.1%).23

Select eligibility criteria2,3,*

Patient-specific

Aged ≥18 years

Thermal burn, 3% to 49% TBSA

Sufficient healthy skin designated as a donor site in the event that the StrataGraft treatment site requires an autograft

Treatment site–specific

Thermal burns on the torso, arms, or legs, with intact dermal elements (ie, DPT) for which excision and autograft are clinically indicated

Total of both study treatment areas ≤2000 cm2

Treatment sites randomized (N=71)

Graphic depicting a person who was treated with meshed autograft (Left) vs. StrataGraft (Right) Graphic depicting a person who was treated with meshed autograft (Left) vs. StrataGraft (Right)

*Visit clinicaltrials.gov and reference NCT03005106 for the complete list of eligibility criteria.