| The performance of a hemostatic agent based on oxidized regenerated cellulose--polyglactin 910 composite in a liver defect model in immunocompetent and athymic rats. | |
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MedLine Citation:
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PMID: 20144845 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Many surgical methods and hemostatic agents can be used to achieve and maintain hemostasis in surgical fields. Numerous clinical situations exist where current treatment modalities are neither effective nor practical. Assessment of new hemostats primarily targets efficacy. However, the biocompatibility and healing properties associated with hemostats are crucial for regulatory approval and product acceptance. Standard biocompatibility and healing studies may not be appropriate for hemostats containing active biologics. Liver defects in NTac:NIH-Whn (athymic) and Sprague Dawley Outbred (immunocompetent) rats were treated with Fibrin Pad (absorbable matrix containing human-derived biologics) or the matrix only. Defects were evaluated at 14 and 28 days post-implantation. As expected, Fibrin Pad in immunocompetent rats induced a cellular immune response. Unexpectedly, biologically significant decreases in healing, material absorption, and local fibrin degradation were also present. Evaluation of Fibrin Pad in immunocompetent animal models must consider potentially significant alterations in healing, material absorption, and local fibrin degradation, in addition to the expected immune response; none of which may be relevant when Fibrin Pad is used in the clinical setting. These considerations are essential when standard efficacy and biocompatibility studies assessing Fibrin Pad are submitted for regulatory consideration or utilized as pre-clinical translational studies. |
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Authors:
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Tim R Muench; Wei Kong; Alex M Harmon |
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Publication Detail:
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Type: Comparative Study; Journal Article; Research Support, Non-U.S. Gov't Date: 2010-02-09 |
Journal Detail:
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Title: Biomaterials Volume: 31 ISSN: 1878-5905 ISO Abbreviation: Biomaterials Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-03-11 Completed Date: 2010-08-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8100316 Medline TA: Biomaterials Country: England |
Other Details:
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Languages: eng Pagination: 3649-56 Citation Subset: IM |
Copyright Information:
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Copyright 2010 Elsevier Ltd. All rights reserved. |
Affiliation:
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ETHICON, Inc. (a Johnson & Johnson Company), PO Box 151, Route 22 West, Somerville, NJ 08876-0151, USA. tmuench@its.jnj.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Cellulose / chemistry* Hemostatics / chemistry, pharmacology* Immunity, Cellular Immunocompetence* Liver / physiopathology* Oxidation-Reduction Polyglactin 910 / chemistry* Rats Rats, Nude |
| Chemical | |
Reg. No./Substance:
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0/Hemostatics; 34346-01-5/Polyglactin 910; 9004-34-6/Cellulose |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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