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1 KISEP Rhinology Korean J Otolaryngol 2005;48: 부비동수술에서의 GUARDIX-SL : 전임상동물실험 유찬기 1 이창호 1 강창우 1 이건익 1 노계연 1 최지연 1 홍석찬 1 장철 1 이영우 2 이영무 2 김진홍 3 GUARDIX-SL in Sinus Surgery:A Preclinical Animal Study Chan-Kee Yoo, MD 1, Chang Ho Lee, MD 1, Chang Woo Kang, MD 1, Kon Ik Lee, MD 1, Kye Youn Ro, MD 1, Ji Yeon Choi, MD 1, Seok-Chan Hong, MD 1, Chol Chang MD 1, Young Woo Lee, MS 2, Young Moo Lee, PhD 2 and Jin Hong Kim, PhD 3 1 Department of Otolaryngology-Head & Neck Surgery, College of Medicine, Pochon CHA University, Seongnam 2 School of Chemical Engineering, College of Engineering, Hanyang University, Seoul and 3 Biorane Co., Seoul, Korea ABSTRACT Background and Objectives:The most frequent complication of FESS (functional endoscopic sinus surgery) is stenosis of the operation site. The complication may influence the postoperative wound healing and the outcome of surgery. There are several measures proposed to prevent the complication. We sought to determine the efficacy of GUARDIX-SL which is made from sodium hyaluronate and sodium carboxymethylcellulose in soluble form. Materials and Method:For 7 rabbits, we made a surgical opening anterior to sinus ostium of the maxillary sinuses on both sides. We put the gelfoams soaked with GUARDIX-SL into the left openings and those soaked with normal saline into the right openings as a control group. We measured the size of the openings after two weeks. Results:There was no synechiae in GUARDIX-SL group whereas we found synechiae developed in two openings in the control group. The mean area of the opening was 9.29 mm 2 and 1.61 mm 2 in GUARDIX-SL group and the control group (p=0.027), respectively. Conclusion:GUARDIX-SL was effective in reducing postoperative stenosis in the animal model. (Korean J Otolaryngol 2005;48: ) KEY WORDS:Sodium hyaluronate Sodium carboxymethylcellulose Stenosis Adhesions

2 동물실험을통한부비동수술에서의 GUARDIX-SL Korean J Otolaryngol 2005;48:

the GUARDIX-SL to prevent postoperative adhesion.

DMaking openings in the both maxillary sinuses.

right opening and gelfoam soaked with the

GMaxillary sinus opening of the control.

IMeasuring the opening size by transparent

Status of surgical antrostomy on postoperative 2

N7 5 2 1.611.78 S.D. GUARDIX-SL N7 7 0 9.296.

Gross specimen shows the maxillary sinuses

3 유찬기외 A B C D E F G H I Fig. 1. Operation process to determine the efficacy of the GUARDIX-SL to prevent postoperative adhesion. AShaving the hair of the ridge of the nose. BSterilization with povidone iodine. CT-shape incision. DMaking openings in the both maxillary sinuses. EApplying gelfoam soaked with saline into the right opening and gelfoam soaked with the GUARDIX-SL into the left opening. F Skin suture. GMaxillary sinus opening of the control. HMaxillary sinus opening of the GUARDIX-SL. IMeasuring the opening size by transparent marker. Table 1. Status of surgical antrostomy on postoperative 2 weeks Open Closed Size of opening mm 2 Control N S.D. GUARDIX-SL N S.D. p0.027 Fig. 2. Gross specimen shows the maxillary sinuses openings in postoperative 2 weeks. The right nasal cavity of rabbit with saline soaking shows closed state and the left nasal cavity of rabbit with the GUARDIX-SL soaking shows open state

and the biopsied tissue from the left nasal cavity of rabbit with GUARDIX-SL

4 동물실험을통한부비동수술에서의 GUARDIX-SL A B Fig. 3. The biopsied tissue from the right nasal cavity of rabbit with saline soaking A and the biopsied tissue from the left nasal cavity of rabbit with GUARDIX-SL soaking B show minimal nonspecific infiltration of inflammatory cells H-E, Korean J Otolaryngol 2005;48:

5 유찬기외 - REFERENCES 1) Chung JH, Cosenza MJ, Rahbar R, Metson RB. Mitomycin C for the prevention of adhesion formation after endoscopic sinus surgery: A randomized, controlled study. Otolaryngol Head Neck Surg 2002;126: ) Ramadan HH. Surgical causes of failure in endoscopic sinus surgery. Laryngoscope 1999;109: ) Burns JW, Colt MJ, Burgees LS, Skinner KC. Preclinical evaluation of seprafilm TM bioresorbable membrane. Eur J Surg Suppl 1997;577: ) Elkins TE, Bury RJ, Ritter JL, Ling FW, Ahokas RA, Homsey CA, et al. Adhesion prevention by solutions of sodium carboxymethylcellulose in the rat. Part I. Fertil Steril 1984;41: ) Fredericks CM, Kotry L, Holtz G, Askalani AH, Serour GI. Adhesion prevention in the rabbit with sodium carboxymethylcellulose solutions. Am J Obstet Gynecol 1986;155: ) Shim HS, Lee YW, Lee YM, Oh YH, Kwon SW, Kim JH, et al. Evaluation of resorbable materials for preventing surgical adhesion on rat experiment. J Korean Surg Soc 2002;63: ) Kimmelman CP, Edelstein DR, Cheng HJ. Sepragel sinus (hylan B) as a postsurgical dressing for endoscopic sinus surgery. Otolaryngol Head Neck Surg 2001;125: ) Jacob A, Faddis BT, Chole RA. MeroGel hyaluronic acid sinonasal implants: Osteogenic implications. Laryngoscope 2002;112: ) Rho JL, Kim AY. Application of mitomycin C after transoral removal of submandibular stones and sialodochoplasty. Laryngoscope 2005;115: ) Rahal A, Peloquin L, Ahmarani C. Mitomycin C in sinus surgery: preliminary results in a rabbit model. J Otolaryngol 2001;30: ) Ingrams DR, Volk MS, Biesman BS, Pankratov MM, Shapshay SM. Sinus surgery: Does mitomycin C reduce stenosis? Laryngoscope 1998; 108:

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