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

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.

Efficacy evaluation of SurgiGuard® in partially hepatectomized pigs

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.