Efficacy evaluation of SurgiGuard® in partially hepatectomized pigs.
OBJECTIVE
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.
Department of Hepatobiliary and Pancreatic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Sung Hyun
SH
Kim
Department of Quality Assurance, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.
Hye Sung
HS
Yoon
Department of Biology and Clinical Pharmacology, Samyang Biopharmaceuticals Corporation, Daejeon, Korea.
Chang Hoon
CH
In
Department of Hepatobiliary and Pancreatic Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Kyung Sik
KS
Kim
Animal model; Hemostatic; Hepatectomy; Histopathology; Oxidized regenerated cellulose