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J Surg Res. 2019 Jul;239:269-277. doi: 10.1016/j.jss.2019.01.060. Epub 2019 Mar 16.

Expanding Hydrophobically Modified Chitosan Foam for Internal Surgical Hemostasis: Safety Evaluation in a Murine Model.

Author information

1
Regenerative Bioscience Center, University of Georgia, Athens, Georgia.
2
gel-e, Inc, College Park, Maryland. Electronic address: matt@gel-e.co.
3
Department of Chemical and Biomolecular Engineering, University of Maryland, College Park, Maryland.
4
Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, Georgia.
5
Regenerative Bioscience Center, University of Georgia, Athens, Georgia. Electronic address: lohitash@uga.edu.

Abstract

BACKGROUND:

A novel injectable expanding foam based on hydrophobically modified chitosan (HM-CS) was developed to improve hemostasis during surgeries. HM-CS is an amphiphilic derivative of the natural biopolymer chitosan (CS); HM-CS has been shown to improve the natural hemostatic characteristics of CS, but its internal safety has not been systematically evaluated. The goal of this study was to compare the long-term in vivo safety of HM-CS relative to a commonly used fibrin sealant (FS), TISSEEL (Baxter).

METHODS:

Sixty-four Sprague-Dawley rats (275-325 g obtained from Charles River Laboratories) were randomly assigned to control (n = 16) or experimental (n = 48) groups. Samples of the test materials (HM-CS [n = 16], CS [n = 16], and FS [n = 16]) applied to a nonlethal liver excision (0.4 ± 0.3 g of the medial lobe) in rats were left inside the abdomen to degrade. Animals were observed daily for signs of morbidity and mortality. Surviving animals were sacrificed at 1 and 6 wk; the explanted injury sites were microscopically assessed.

RESULTS:

All animals (64/64) survived both the 1- and 6-wk time points without signs of morbidity. Histological examination showed a comparable pattern of degradation for the various test materials. FS remnants and significant adhesions to neighboring tissues were observed at 6 wk. Residual CS and HM-CS were observed at the 6 wk with fatty deposits at the site of injury. Minimal adhesions were observed for CS and HM-CS.

CONCLUSIONS:

The internal safety observed in the HM-CS test group after abdominal implantation indicates that injectable HM-CS expanding foam may be an appropriate internal use hemostatic candidate.

KEYWORDS:

Biodegradation; Chitosan; Fibrin sealant; Foam; Hemostasis; in vivo study

PMID:
30884383
DOI:
10.1016/j.jss.2019.01.060

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