Korean J Hepatobiliary Pancreat Surg.  2016 Aug;20(3):102-109. 10.14701/kjhbps.2016.20.3.102.

Efficacy evaluation of SurgiGuard® in partially hepatectomized pigs

Affiliations
  • 1Department of Hepatobiliary and Pancreatic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. KSKIM88@yuhs.ac
  • 2Department of Quality Assurance, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.
  • 3Department of Biology and Clinical Pharmacology, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.

Abstract

BACKGROUNDS/AIMS
This study evaluated the hemostatic effects of a novel oxidized regenerated cellulose, SurgiGuard®, during liver surgery, using a reproducible and clinically relevant animal model.
METHODS
Fifteen mini-pigs underwent left partial hepatectomy. They were randomized to treatment of the resected surface with SurgiGuard® (Group C [test], n=5), Surgicel® (Group B [reference], n=5), or nothing (Group A [control], n=5). Blood loss was measured 5, 7 and 9 min after resection. Time to hemostasis was recorded. Mini-pigs were necropsied 4 or 6 weeks postoperatively to evaluate toxicity changes and material dissolution.
RESULTS
The median resected liver weight was 2.13 g (2.02-2.20) in control group, 2.04 g (2.01-2.13) in reference group, and 2.01 g (1.99-2.12) in test group (p=0.024). Median total blood loss was 57.18 g (52.02-59.54) in control group, 32.52 g (27.66-35.10) in reference group, and 35.52 g (25.70-38.71) in test group (p=0.008). Blood loss at 0-5 minutes and 7-9 minutes was significantly different between groups (p=0.009 and p=0.006, respectively). At necropsy, no hematomas, granulomas, or adhesions were noted in any group. Histopathological analysis revealed no changes suggesting toxicity related to SurgiGuard®.
CONCLUSIONS
SurgiGuard® is as effective as Surgicel® in achieving hemostasis after porcine partial liver resection.

Keyword

Animal model; Hemostatic; Hepatectomy; Histopathology; Oxidized regenerated cellulose

MeSH Terms

Cellulose
Granuloma
Hematoma
Hemostasis
Hepatectomy
Liver
Models, Animal
Swine*
Cellulose
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