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StrataGraft is the first approved donor site–free alternative to autograft for DPT burns

Reduced or eliminated harvesting (coprimary end point) StrataGraft eliminated donor site harvesting for 96% (68 of 71) of DPT burns in the pivotal study

Significant reduction in donor site harvesting was demonstrated by StrataGraft at month 3 as measured by percent area autografted1

  • Of 71 patients studied, 3 required part or all of the area treated with StrataGraft® to be autografted1
  • 2 of those 3 patients also required regrafting of the original autograft treatment site1
Bar chart comparing the percent area autografted using StrataGraft and autograft Bar chart comparing the percent area autografted using StrataGraft and autograft

Difference: P<.0001.

*102% reflects the need for additional autograft (ie, regrafting) at the autograft treatment site, with 2 patients requiring regrafting.2

Achieved 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

Clinically similar cosmesis outcomes to autograft (secondary end point) Clinically similar cosmesis outcomes to autograft—in a single procedure

Immediate, translucent coverage.4 Durable wound closure1

Images of StrataGraft treatment sites and autograft treatment sites from representative patients

POSAS observer total score (secondary end point) Clinically similar cosmesis outcomes to autograft as determined by the criteria of POSAS

At month 12, mean Patient and Observer Scar Assessment Scale (POSAS) observer total score was 15.6 for StrataGraft treatment sites compared with 16.3 for autograft treatment sites2

Bar chart comparing POSAS scores for StrataGraft and autograft Bar chart comparing POSAS scores for StrataGraft and autograft
Reverse side of POSAS bar chart describes the criteria Reverse side of POSAS bar chart describes the criteria

Each item of the POSAS observer scale is rated using a 10-point score. The total score is the sum of the first 6 scores and does not include the overall opinion.

A lower POSAS score represents a more favorable outcome

(ie, 1=normal skin, 10=worst scarring imaginable)

Vascularization

Presence of vessels in scar tissue assessed by the amount of redness6

Pigmentation

Brownish coloration of the scar by pigment (melanin)6

Thickness

Average distance between the subcutical-dermal border and the epidermal surface of the scar6

Relief

The extent to which surface irregularities are present6

Pliability

Suppleness of the scar tested by wrinkling the scar between the thumb and index finger6

Surface area

Surface area of the scar in relation to the original wound area6

Overall opinion

The overall appearance of the scar, independent of the other criteria6

These data represent individual components of a composite end point. As this study was not statistically powered to detect an effect of StrataGraft on individual components of POSAS, these results should be interpreted with caution, and no definitive conclusions regarding any individual score should be drawn.

Study design
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.