A Multicenter Clinical Trial of a Biosynthetic Skin Replacement, Dermagraft-TC, Compared with Cryopreserved Human Cadaver Skin for Temporary Coverage of Excised Burn Wounds

Purdue, Gary F.; Hunt, John L.; Still, Joseph M.; Law, Edward; Herndon, David N.; Goldfarb, I W; Schiller, William R.; Hansbrough, John F.; Hickerson, William L.; Himel, Harvey N.; Kealey, Gerald P.; Twomey, John; Missavage, Anne E.; Solem, Lynn D.; Davis, Michelle; Totoritis, Mark C.; Gentzkow, Gary D.

doi:10.1097/00004630-199701000-00009

Cited by 152 publications

(59 citation statements)

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“…Great progress has been made in many tissue systems that have allowed translational discoveries to be adapted for patient use, including the FDA approval of engineered skin. 20 Other tissue systems are currently in clinical trials. 21 These translational successes have been in tissues that require less vascularity.…”

Section: Discussionmentioning

confidence: 99%

Analyzing Structure and Function of Vascularization in Engineered Bone Tissue by Video-Rate Intravital Microscopy and 3D Image Processing

Pang

Tsigkou

Spencer

et al. 2015

Tissue Engineering Part C: Methods

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Vascularization is a key challenge in tissue engineering. Three-dimensional structure and microcirculation are two fundamental parameters for evaluating vascularization. Microscopic techniques with cellular level resolution, fast continuous observation, and robust 3D postimage processing are essential for evaluation, but have not been applied previously because of technical difficulties. In this study, we report novel video-rate confocal microscopy and 3D postimage processing techniques to accomplish this goal. In an immune-deficient mouse model, vascularized bone tissue was successfully engineered using human bone marrow mesenchymal stem cells (hMSCs) and human umbilical vein endothelial cells (HUVECs) in a poly (d,l-lactide-co-glycolide) (PLGA) scaffold. Video-rate (30 FPS) intravital confocal microscopy was applied in vitro and in vivo to visualize the vascular structure in the engineered bone and the microcirculation of the blood cells. Postimage processing was applied to perform 3D image reconstruction, by analyzing microvascular networks and calculating blood cell viscosity. The 3D volume reconstructed images show that the hMSCs served as pericytes stabilizing the microvascular network formed by HUVECs. Using orthogonal imaging reconstruction and transparency adjustment, both the vessel structure and blood cells within the vessel lumen were visualized. Network length, network intersections, and intersection densities were successfully computed using our custom-developed software. Viscosity analysis of the blood cells provided functional evaluation of the microcirculation. These results show that by 8 weeks, the blood vessels in peripheral areas function quite similarly to the host vessels. However, the viscosity drops about fourfold where it is only 0.8 mm away from the host. In summary, we developed novel techniques combining intravital microscopy and 3D image processing to analyze the vascularization in engineered bone. These techniques have broad applicability for evaluating vascularization in other engineered tissues as well.

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Section: Discussionmentioning

confidence: 99%

Analyzing Structure and Function of Vascularization in Engineered Bone Tissue by Video-Rate Intravital Microscopy and 3D Image Processing

Pang

Tsigkou

Spencer

et al. 2015

Tissue Engineering Part C: Methods

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“…It is more readily removed than allograft, with significantly higher level of patient satisfaction (3,56). There have been no reported adverse reactions to Dermagraft ® , with no evidence of rejection, early deterioration, or separation from wound [Hansbrough et al 1997].…”

Section: Synthetic Materials Dermagraft ®mentioning

confidence: 99%

“…Human neonatal foreskin (allogeneic) fibroblasts are cultured and proliferate on an inner nylon mesh of fibres that are embedded in an outer silastic layer for 4 to 6 weeks (25, 36) forming a dense cellular tissue which contains high levels of secreted human matrix proteins as well as multiple growth factors (58). A multicentre, randomized, controlled, paired within patient study in 66 patients with 132 excised burn wounds showed this skin substitute to be as effective as human cadaver skin and was successful as a temporary wound coverage after excision of the eschar from burn wounds (56). This fibroblast-collagen-nylon-silicone mesh is US FDA-approved for the treatment of burn wounds (it was the first human-based, bioengineered temporary skin substitute for the treatment of excised full-thickness and partial-thickness burns approved by the US FDA in 1997 (38), and advantages include immediate availability, ease of storage (25) and direct visual monitoring of the wound bed (due to transparency) (38).…”

Section: Transcyte ® (Dermagraft-tc ® )mentioning

confidence: 99%

The Use of Dermal Substitutes in Burn Surgery: Acute Phase

Arno¹,

Jeschke²

2013

Dermal Replacements in General, Burn, and Plastic Surgery

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Dermal substitutes are increasingly becoming an essential part of the burn care strategy. During the acute phase of burn treatment, dermal substitutes improve functional and cosmetic results long-term and thus increase quality of life. In the chronic wound setting, dermal substitutes are used to reconstruct and improve burn scars and other defects. Despite some successes in the use of dermal substitutes there are more needs and requirements to further improve outcomes and hence further research is required not only to strengthen scientific evidence regarding their effects but also to develop new technology and products. Dermal substitutes also emerge as pivotal research strategies to develop adequate scaffolds for stem cells, tissue engineering and regenerative medicine applications to obtain long-lasting and scarless artificial skin. This review discusses status-quo of dermal substitutes and novel strategies in the use of dermal substitutes with a focus on burn care.

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“…36,37 ICX-SKN, TransCyte (also known as Dermagraft-TC) and Dermagraft are cellular dermal allografts which use a scaffold of dermal collagen that is seeded with neonatal fibroblasts to stimulate cells within the host's wound to promote healing. [38][39][40][41][42][43][44] Composite allograft products are the most advanced and closest products to living skin that are currently commercially available. Apligraft and Orcelare are the currently available products.…”

Section: Types Of Skin Substitutesmentioning

confidence: 99%