Chinese Journal of Tissue Engineering Research January 15, 2016 Vol.20, No.3

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1 Chinese Journal of Tissue Engineering Research January 15, 2016 Vol.20, No.3 1, ( ). [J] (3): DOI: /j.issn ORCID: () β tpa upa :R318 :A : (2016) / β (tpa)(upa) Ethical issues in animal experimentation β (2012s011). Wu Zhi-min 1, 2, Cui Hong-li 2, Liu Guo-hui 3 ( 1 Center for Gastrointestinal Cancer, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing , China; 2 Department of General Surgery, Beijing Chuiyangliu Hospital, Beijing , China; 418 P.O. Box 10002, Shenyang

2 . 3 Department of Emergency Surgery, the First Hospital of Jilin University, Changchun , Jilin Province, China) Wu Zhi-min, M.D., Associate chief physician, Center for Gastrointestinal Cancer, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing , China Corresponding author: Liu Guo-hui, Department of Emergency Surgery, the First Hospital of Jilin University, Changchun , Jilin Province, China Subject headings: Tissue Adhesions; Hyaluronic Acid; Carboxymethylcellulose Sodium; Tissue Engineering Funding: the Scientific Research Project of Jilin Provincial Health Department, No. 2012s011 Optimal dose and mechanism of sodium hyaluronate/carboxymethylcellulose for prevention of postoperative peritoneal adhesions: study protocol for a randomized controlled trial Abstract BACKGROUND: Local application of barriers is an effective way to prevent postoperative peritoneal adhesions. In previous experiments, a patented anti-adhesion material, sodium hyaluronate/carboxymethylcellulose, has been prepared. This glue-like polymer material has good biocompatibility, and because of its fluidity and compressibility, it can wriggle with the organs and diffuse in the entire abdominal cavity, and thereby play alubricant role to separate the intestine and peritoneum and reduce tissue adhesion. METHODS/DESIGN: A randomized controlled animal experiment has been designed. Animal models of peritoneal adhesion are made in New Zealand rabbits followed by injection of sodium hyaluronate/ carboxymethylcellulose at different concentrations and doses. The optimal concentration and dose of sodium hyaluronate/ carboxymethylcellulose is screened by comparing percentage of peritoneal adhesion between treatment and control groups. Anti-adhesion mechanism of sodium hyaluronate/carboxymethylcellulose is explored through the detection of fibroblast growth factor, endothelial cell growth factor, transforming growth factor β and serum tissue-type plasminogen activator, urokinase-type plasminogen activator and fibrinogen. DISCUSSION: This study will be powered to provide experimental evidence for sodium hyaluronate/carboxymethylcellulose in clincial prevention of postoperative peritoneal adhesion, as well as feasible ideas for exploring the anti-adhesion mechanism of sodium hyaluronate/carboxymethylcellulose. ETHICAL APPROVAL: This study was approved by the Ethics Committee of the First Hospital of Jilin University. The disposal of animals was in line with the Guideline for the Care and Use of Laboratory Animals formulated by the Ministry of Science and Technology, China in 2006 and the Ethical Issues in Animal Experimentation released in Cite this article: Wu ZM, Cui HL, Liu GH. Optimal dose and mechanism of sodium hyaluronate/carboxymethylcellulose for prevention of postoperative peritoneal adhesions: study protocol for a randomized controlled trial. Zhongguo Zuzhi Gongcheng Yanjiu. 2016;20(3): Experimental design Academic background and theoretical basis 2.1 [1] 90% 3.6% [2-3] 2.2 [4-5] Co-Tex [6-7] [8] PLGA PLGA [9] [10] Al 3+ Fe 3+ Zn 2+ [11-13] 2009 [14] ISSN CN /R CODEN: ZLKHAH 419

3 . (tpa)(upa) β(tgf-β) (FGF) 1 1 tpa upa TGF-β FGF EGF tpaupatgf-β βfgfegf [15-16] [17-19] 3 Study purpose Animal selection 4.1 (1) (2)(2.4±0.3) kg (3) (4) 4.2 (1) (2) (3) 5 Interventions P.O. Box 10002, Shenyang

4 . 12 h3%(1 ml/kg) 5 cm 20 cm 0.8 cm d (3% 3 ml/240 g)12 d Study protocol β (tpa)(upa) 6.4 (1)( ) (2) (3) (4) (5)( tpaupaβ ) Outcome measurement 7.1 (tpa) (upa) β(tgf-β)(fgf) 7.2 [20] () Statistical analysis 8.1 P < SAS 9.0 () (%) (tpaupa )x _ ±s t Administration Terms and conditions ISSN CN /R CODEN: ZLKHAH 421

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