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The performance of a hemostatic agent based on oxidized regenerated cellulose – polyglactin 910 composite in a liver defect model in immunocompetent and athymic rats

Paper ID Volume ID Publish Year Pages File Format Full-Text
9719 643 2010 8 PDF Available
Title
The performance of a hemostatic agent based on oxidized regenerated cellulose – polyglactin 910 composite in a liver defect model in immunocompetent and athymic rats
Abstract

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.

Keywords
Hemostasis; Thrombin; Fibrinogen; Immune response; Animal model; Biocompatibility
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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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Publisher
Database: Elsevier - ScienceDirect
Journal: Biomaterials - Volume 31, Issue 13, May 2010, Pages 3649–3656
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us