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With StrataGraft, you can heal without harvesting

StrataGraft® is the first approved donor site–free alternative to autograft for deep partial-thickness (DPT) burns

Coprimary end point

StrataGraft is a single-procedure DPT burn treatment that was shown in the pivotal trial to eliminate donor site harvesting in

96% of treated sites1

Handles like an autograft

StrataGraft delivers viable cells to support the body’s own ability to heal

Designed with both dermal and epidermal layers composed of well-characterized human cells1

  • Metabolically active cells1

    • Produces and secretes cytokines and other wound-healing factors

  • Growth factors and cytokines are known to be involved in wound repair and regeneration1

  • Does not permanently engraft and is gradually replaced by a patient’s own cells1

    • DNA from StrataGraft was not detectable at month 3
    • Attains durable wound closure

Provides durable wound closure (coprimary end point) StrataGraft treatment sites achieved durable wound closure without the need to create a second wound

83% (59 of 71) of StrataGraft-treated wounds and 86% (61 of 71) of autograft-treated wounds achieved durable closure at month 3; missing data were imputed as failures1,2,*

Graph comparing the mean percent reepithelialization of StrataGraft and autograft at day 28, month 2, month 3, month 4, month 6, and month 12 Graph comparing the mean percent reepithelialization of StrataGraft and autograft at day 28, month 2, month 3, month 4, month 6, and month 12
  • For patients who completed the month 3 visit, 92% (59 of 64) demonstrated durable wound closure at the StrataGraft treatment site. For reference, 95% (61 of 64) demonstrated durable wound closure at the autograft treatment site2,*
  • After month 3, DPT burn wounds treated with StrataGraft demonstrated equivalent wound reepithelialization to those treated with autograft2
  • 3 patients did not achieve 100% reepithelialization at month 3. However, these patients did achieve >95% reepithelialization2

*Durable wound closure was defined as 100% skin reepithelialization without drainage or dressing requirements at 2 consecutive evaluations at least 2 weeks, but no greater than 5 months, apart. At early study sessions, 100% reepithelialization was observed more frequently for autograft treatment sites relative to StrataGraft treatment sites, likely due to different mechanisms of healing.2,3

Study design

Designed to fit into the workflow StrataGraft handles like an autograft

Unlike an autograft, once placed, StrataGraft does not permanently engraft and is replaced by the patient’s own cells. In addition, StrataGraft can:

  • Provide immediate coverage1,2

  • Conform to the wound bed1

  • Be meshed to allow for exudate management1,*

  • Adapt to fit wound size1

  • Prevent moisture loss4

  • Be anchored with staples, sutures, or tissue adhesive, such as cyanoacrylate or fibrin glue1

StrataGraft is a translucent, adaptable, biologically active construct designed to fit into your workflow1,5

*StrataGraft measures at 8 cm × 12.5 cm and can be meshed at ratios up to 1:1.1

a dermatome with the words 'heal without harvesting' where the blade should be
How did StrataGraft perform in clinical trials?

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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
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.

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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.1,2

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%).2

Select eligibility criteria2,5,2,6,*

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 autograft on the left side and StrataGraft on the right side Graphic depicting a person who was treated with autograft on the left side and StrataGraft on the right side

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