Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries

J. H. Holmes, J. A. Molnar, J. W. Shupp, William Hickerson, Booker T. King, K. N. Foster, B. A. Cairns, J. E. Carter

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Introduction: Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL® Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Methods: A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. Results: At 8 weeks, 85% of the Control-treated wounds were healed compared with 92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32% with the use of RECELL (p < 0.001), establishing the superiority of RECELL treatment for reducing donor skin requirements. Secondary effectiveness and safety outcomes were similar between the treatments. Conclusions: In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.

Original languageEnglish (US)
Pages (from-to)772-782
Number of pages11
JournalBurns
Volume45
Issue number4
DOIs
StatePublished - Jun 1 2019

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Autografts
Tissue Donors
Safety
Skin
Wounds and Injuries
Transplants
Point-of-Care Systems
Burns
Therapeutics
Standard of Care
Autologous Transplantation
Dermis
Wound Healing
Cicatrix
Suspensions
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Surgery
  • Emergency Medicine
  • Critical Care and Intensive Care Medicine

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Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. / Holmes, J. H.; Molnar, J. A.; Shupp, J. W.; Hickerson, William; King, Booker T.; Foster, K. N.; Cairns, B. A.; Carter, J. E.

In: Burns, Vol. 45, No. 4, 01.06.2019, p. 772-782.

Research output: Contribution to journalArticle

Holmes, J. H. ; Molnar, J. A. ; Shupp, J. W. ; Hickerson, William ; King, Booker T. ; Foster, K. N. ; Cairns, B. A. ; Carter, J. E. / Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. In: Burns. 2019 ; Vol. 45, No. 4. pp. 772-782.
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abstract = "Introduction: Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL{\circledR} Autologous Cell Harvesting Device (RECELL{\circledR} System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Methods: A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. Results: At 8 weeks, 85{\%} of the Control-treated wounds were healed compared with 92{\%} of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32{\%} with the use of RECELL (p < 0.001), establishing the superiority of RECELL treatment for reducing donor skin requirements. Secondary effectiveness and safety outcomes were similar between the treatments. Conclusions: In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.",
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T1 - Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries

AU - Holmes, J. H.

AU - Molnar, J. A.

AU - Shupp, J. W.

AU - Hickerson, William

AU - King, Booker T.

AU - Foster, K. N.

AU - Cairns, B. A.

AU - Carter, J. E.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Introduction: Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL® Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Methods: A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. Results: At 8 weeks, 85% of the Control-treated wounds were healed compared with 92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32% with the use of RECELL (p < 0.001), establishing the superiority of RECELL treatment for reducing donor skin requirements. Secondary effectiveness and safety outcomes were similar between the treatments. Conclusions: In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.

AB - Introduction: Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL® Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1 cm2 of the patient's skin to treat up to 80 cm2 of excised burn. Methods: A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. Results: At 8 weeks, 85% of the Control-treated wounds were healed compared with 92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32% with the use of RECELL (p < 0.001), establishing the superiority of RECELL treatment for reducing donor skin requirements. Secondary effectiveness and safety outcomes were similar between the treatments. Conclusions: In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.

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