Yonsei Med J.  2017 Jan;58(1):195-205. 10.3349/ymj.2017.58.1.195.

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

Affiliations
  • 1Department of Hepatobiliary and Pancreatic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. kskim88@yuhs.ac
  • 2Department of Pathology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 3Department of Quality Assurance, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.
  • 4Department of Research and Development, Medical Device Program, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.

Abstract

PURPOSE
Adequate hemostasis is important for postoperative outcomes of abdominal surgery. This study evaluated the hemostatic effects and accompanying histopathological changes of a novel oxidized regenerated cellulose, SurgiGuard®, during abdominal surgery.
MATERIALS AND METHODS
Ten pigs underwent wedge resection of the spleen (1×1 cm) and liver (1.5×1.5 cm). The resected surface was covered with Surgicel® fabric or fibril type (Group A) or SurgiGuard® fabric or fibril type (Group B). Surgicel® and SurgiGuard® were randomized for attachment to the resected surface by fabric type (n=5) or fibril type (n=5). Blood loss was measured 5, 7, and 9 min after resection. Pigs were necropsied 6 weeks postoperatively to evaluate gross and histopathological changes.
RESULTS
There was no significant difference in total blood loss between groups [spleen fabric: Group A vs. Group B, 4.38 g (2.74-6.43) vs. 3.41 g (2.46-4.65), p=0.436; spleen fibril: Group A vs. Group B, 3.44 g (2.82-6.07) vs. 3.60 g (2.03-6.09), p=0.971; liver fabric: Group A vs. Group B, 4.51 g (2.67-10.61) vs. 6.93 g (3.09-9.95), p=0.796; liver fibril: Group A vs. Group B, 3.32 g (2.50-8.78) vs. 3.70 g (2.32-5.84), p=0.971]. Histopathological analysis revealed no significant difference in toxicities related to Surgicel® or SurgiGuard® [inflammation, fibrosis, foreign bodies, and hemorrhage (spleen: p=0.333, 0.127, 0.751, and 1.000; liver: p=0.155, 0.751, 1.000, and 1.000, respectively)].
CONCLUSION
SurgiGuard® is as effective and non-toxic as Surgicel® in achieving hemostasis after porcine abdominal surgery.

Keyword

Animal model; blood loss; hemostatics; histopathology; oxidized regenerated cellulose

MeSH Terms

Animals
*Blood Loss, Surgical/statistics & numerical data
Cellulose, Oxidized/*therapeutic use
Hemostasis, Surgical/*methods
Hemostatics/*therapeutic use
Liver/*surgery
Random Allocation
Spleen/*surgery
Swine
Cellulose, Oxidized
Hemostatics
Surgicel
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