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

Figure

  • Fig. 1 Weight of the resected organs and blood loss in accordance with time and type.

  • Fig. 2 Microscopic findings of resected spleen surface (Fabric type, hematoxylin and eosin stain, ×100).

  • Fig. 3 Microscopic findings of resected spleen surface (Fibril type, hematoxylin and eosin stain, ×100).

  • Fig. 4 Microscopic findings of resected liver surface (Fabric type, hematoxylin and eosin stain, ×100).

  • Fig. 5 Microscopic findings of resected liver surface (Fibril type, hematoxylin and eosin stain, ×100).


Reference

1. Dagi TF. The management of postoperative bleeding. Surg Clin North Am. 2005; 85:1191–1213.
Article
2. Zwischenberger JB, Brunston RL Jr, Swann JR, Conti VR. Comparison of two topical collagen-based hemostatic sponges during cardiothoracic procedures. J Invest Surg. 1999; 12:101–106.
Article
3. Achneck HE, Sileshi B, Jamiolkowski RM, Albala DM, Shapiro ML, Lawson JH. A comprehensive review of topical hemostatic agents: efficacy and recommendations for use. Ann Surg. 2010; 251:217–228.
4. Tan SR, Tope WD. Effectiveness of microporous polysaccharide hemospheres for achieving hemostasis in mohs micrographic surgery. Dermatol Surg. 2004; 30:908–914.
Article
5. Tanizawa Y, Bando E, Kawamura T, Tokunaga M, Ono H, Terashima M. Early postoperative anastomotic hemorrhage after gastrectomy for gastric cancer. Gastric Cancer. 2010; 13:50–57.
Article
6. Martínez-Serrano MA, Parés D, Pera M, Pascual M, Courtier R, Egea MJ, et al. Management of lower gastrointestinal bleeding after colorectal resection and stapled anastomosis. Tech Coloproctol. 2009; 13:49–53.
Article
7. Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, et al. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011; 13:528–535.
Article
8. Jones S, May AK. Postoperative gastrointestinal hemorrhage. Surg Clin North Am. 2012; 92:235–242.
Article
9. Cata JP, Wang H, Gottumukkala V, Reuben J, Sessler DI. Inflammatory response, immunosuppression, and cancer recurrence after perioperative blood transfusions. Br J Anaesth. 2013; 110:690–701.
Article
10. Nash GF, Chopada A, Patel H, Kakkar AK. Stored blood products stimulate cancer growth. Br J Surg. 2002; 89:19.
11. Kanko M, Liman T, Topcu S. A low-cost and simple method to stop intraoperative leakage-type bleeding: use of the vancomycin-oxidized regenerated cellulose (ORC) sandwich. J Invest Surg. 2006; 19:323–327.
Article
12. Frantz VK. Absorbable cotton, paper and gauze: (oxidized cellulose). Ann Surg. 1943; 118:116–126.
13. Simo KA, Hanna EM, Imagawa DK, Iannitti DA. Hemostatic agents in hepatobiliary and pancreas surgery: a review of the literature and critical evaluation of a novel carrier-bound fibrin sealant (tachoSil). ISRN Surg. 2012; 2012:729086.
Article
14. Sabel M, Stummer W. The use of local agents: surgicel and surgifoam. Eur Spine J. 2004; 13:Suppl 1. S97–S101.
Article
15. Phillips JD, Kim CS, Fonkalsrud EW, Zeng H, Dindar H. Effects of chronic corticosteroids and vitamin A on the healing of intestinal anastomoses. Am J Surg. 1992; 163:71–77.
Article
16. Chvapil M, Owen JA, DeYoung DW. A standardized animal model for evaluation of hemostatic effectiveness of various materials. J Trauma. 1983; 23:1042–1047.
Article
17. Koea JB, Batiller J, Patel B, Shen J, Hammond J, Hart J, et al. A phase III, randomized, controlled, superiority trial evaluating the fibrin pad versus standard of care in controlling parenchymal bleeding during elective hepatic surgery. HPB (Oxford). 2013; 15:61–70.
Article
18. Velázquez-Aviña J, Mönkemüller K, Sakai P, Sulbaran M, Chávez-Vargas C, Montalvo Javé E, et al. Hemostatic effect of oxidized regenerated cellulose in an experimental gastric mucosal resection model. Endoscopy. 2014; 46:878–882.
Article
19. Hutchinson RW, Broughton D, Barbolt TA, Poandl T, Muench T, Rockar R, et al. Hemostatic effectiveness of Fibrin pad after partial nephrectomy in swine. J Surg Res. 2011; 167:e291–e298.
Article
20. Matonick JP, Hammond J. Hemostatic efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a heparinized swine spleen incision model. J Invest Surg. 2014; 27:360–365.
Article
21. Muench TR, Kong W, Harmon AM. The performance of a hemostatic agent based on oxidized regenerated cellulose--polyglactin 910 composite in a liver defect model in immunocompetent and athymic rats. Biomaterials. 2010; 31:3649–3656.
Article
22. Giuliani M, Fubelli R, Patrolecco F, Rella R, Borelli C, Buccheri C, et al. Mammographic and ultrasonographic findings of oxidized regenerated cellulose in breast cancer surgery: a 5-year experience. Clin Breast Cancer. 2015; 15:e249–e256.
Article
23. Tomizawa Y. Clinical benefits and risk analysis of topical hemostats: a review. J Artif Organs. 2005; 8:137–142.
Article
24. Dineen P. The effect of oxidized regenerated cellulose on experimental intravascular infection. Surgery. 1977; 82:576–579.
25. Gottrup F, Cullen BM, Karlsmark T, Bischoff-Mikkelsen M, Nisbet L, Gibson MC. Randomized controlled trial on collagen/oxidized regenerated cellulose/silver treatment. Wound Repair Regen. 2013; 21:216–225.
Article
26. Alfieri S, Di Miceli D, Menghi R, Quero G, Cina C, Pericoli Ridolfini M, et al. Role of oxidized regenerated cellulose in preventing infections at the surgical site: prospective, randomized study in 98 patients affected by a dirty wound. Minerva Chir. 2011; 66:55–62.
27. Bullen AW, Losowsky MS. Consequences of impaired splenic function. Clin Sci (Lond). 1979; 57:129–137.
Article
28. Khan PN, Nair RJ, Olivares J, Tingle LE, Li Z. Postsplenectomy reactive thrombocytosis. Proc (Bayl Univ Med Cent). 2009; 22:9–12.
Article
29. Katti DS, Lakshmi S, Langer R, Laurencin CT. Toxicity, biodegradation and elimination of polyanhydrides. Adv Drug Deliv Rev. 2002; 54:933–961.
Article
30. Behbehani S, Tulandi T. Oxidized regenerated cellulose imitating pelvic abscess. Obstet Gynecol. 2013; 121:2 Pt 2 Suppl 1. 447–449.
31. Wang H, Chen P. Surgicel® (oxidized regenerated cellulose) granuloma mimicking local recurrent gastrointestinal stromal tumor: a case report. Oncol Lett. 2013; 5:1497–1500.
Article
32. Postoperative adhesion. evaluation at early second-look procedures. Operative Laparoscopy Study Group. Fertil Steril. 1991; 55:700–704.
33. Raftery AT. Absorbable haemostatic materials and intraperitoneal adhesion formation. Br J Surg. 1980; 67:57–58.
Article
34. Ates U, Ata B, Ortakuz S, Seyhan A, Urman B. Prevention of adhesion formation following ovarian surgery in a standardized animal model: comparative study of Interceed and double layer Surgicell. J Obstet Gynaecol Res. 2008; 34:12–17.
Article
35. Ahmad G, O'Flynn H, Hindocha A, Watson A. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2015; (4):CD000475.
Article
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