Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin)

Towler, Michael A.; Rush, Elaine W.; Richardson, Melissa K.; Williams, Calvin L.

doi:10.1016/j.cpm.2018.02.006

Cited by 38 publications

(26 citation statements)

References 5 publications

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“…Interestingly, three head-to-head RCTs comparing CHSA to BLCC or DSS have shown either equivalency or improved outcomes with CHSA over others. 8 – 10 Of importance to this analysis, however, is that all three of these RCTs also reported either fewer applications or overall cost savings with CHSA compared with BLCC or DSS. Further, in this Medicare claims analysis, all wound types were included, whereas the RCTs focused on only DFU and VLU; this potentially could have impacted the results, although the investigators did not see a significant difference in diagnosis codes among the three cohorts (Table 2 ).…”

Section: Discussionmentioning

confidence: 99%

“…The fewer number of applications of CHSA relative to DSS (Figure 3 ) is consistent with findings from a head-to-head RCT. 10 One explanation is that CHSA is typically applied every other week, whereas DSS is applied weekly. In addition, it is possible that more cell types or the presence of human collagen are important in healing, but there are little data available today to understand the implications for real-world practice.…”

Section: Discussionmentioning

confidence: 99%

“… 5 – 7 Two RCTs comparing CHSA to BLCC and DSS had similar findings, with CHSA having similar VLU outcomes but costing at least 40% less than BLCC per patient and significantly faster healing of DFUs than DSS. 8 – 10 …”

Section: Methodsmentioning

confidence: 99%

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The Health Economic Impact of Living Cell Tissue Products in the Treatment of Chronic Wounds: A Retrospective Analysis of Medicare Claims Data

Barbul

Gelly

Masturzo

2019

Adv Skin Wound Care

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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The Health Economic Impact of Living Cell Tissue Products in the Treatment of Chronic Wounds: A Retrospective Analysis of Medicare Claims Data

Barbul

Gelly

Masturzo

2019

Adv Skin Wound Care

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“…Consequently, little clinical data exist to support the use of CTPs in the treatment of other wounds. TheraSkin (Solsys Medical; Newport News, Virginia) is a bioactive human skin allograft (BSA) that is procured from organ donors while the tissue is viable; the skin is minimally manipulated and proprietarily processed for safety . BSA is indicated for homologous use (ie, human skin to replace human skin) and, as such, appropriate for all wound types and depths if adequate wound bed preparation and vascularity is present.…”

Section: Introductionmentioning

confidence: 99%

“…BSA is comparable to fresh human skin and contains living cells, growth factors, and a native human extracellular matrix . In both RCT and real‐world studies, BSA has been shown to improve healing in VLUs and DFUs, with and without exposed deep structures …”

Section: Introductionmentioning

confidence: 99%

A retrospective matched‐cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone

Gurtner

Garcia

Bakewell³

et al. 2019

International Wound Journal

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Most chronic wounds are related to comorbidities, for which no clinical trials are performed. This retrospective propensity matched-cohort study examined data from 2 074 000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC alone (n = 1997). Multivariate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3% versus 60.3%), particularly wounds with exposed structures (64% versus 50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control group was 2.75x more likely to require amputation than the treatment group. The combination of propensity matching and logistic regression analysis on a particularly large database demonstrated that wounds treated with TheraSkin had higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical transfers (16.1% versus 23.5%) than SOC alone. This study considered data from complex wounds typically excluded from controlled trials and supports the idea that real-world evidence studies can be valid and reliable.

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Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products

Sharma

Zhao

2023

Adv Healthcare Materials

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Impaired wound healing after trauma, disorders, and surgeries impact millions of people globally every year. Dysregulation in orchestrated healing mechanisms and underlying medical complications make chronic wound management extremely challenging. Besides standard‐of‐care treatments including broad spectrum antibiotics and wound‐debridement, novel adjuvant therapies are clinically tested and commercialized. These include topical agents, skin substitutes, growth factor delivery, and stem cell therapies. With a goal to overcome factors playing pivotal role in delayed wound healing, researchers are exploring novel approaches to elicit desirable healing outcomes in chronic wounds. Although recent innovations in wound care products, therapies, and devices are extensively reviewed in past, a comprehensive review summarizing their clinical outcomes is surprisingly lacking. Herein, this work reviews the commercially available wound care products and their performance in clinical trials to provide a statistically comprehensive understanding of their safety and efficacy. The performance and suitability of various commercial wound care platforms, including xenogeneic and allogenic products, wound care devices, and novel biomaterials, are discussed for chronic wounds. The current clinical evaluation will provide a comprehensive understanding of the benefits and drawbacks of the most‐recent approaches and will enable researchers and healthcare providers to develop next‐generation technologies for chronic wound management.

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Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin)

Cited by 38 publications

References 5 publications

The Health Economic Impact of Living Cell Tissue Products in the Treatment of Chronic Wounds: A Retrospective Analysis of Medicare Claims Data

The Health Economic Impact of Living Cell Tissue Products in the Treatment of Chronic Wounds: A Retrospective Analysis of Medicare Claims Data

A retrospective matched‐cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone

Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products

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