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A randomized controlled trial to compare the efficacy of regenerated and non-regenerated oxidized cellulose gauze for the secondary treatment of local bleeding in patients undergoing hepatic resection

Annals of Surgical Treatment and Research 2021년 100권 4호 p.193 ~ 199
Zhang Chengshuo, Fu Dazhi, Wang Fengshan, Zhong Xinping, Yang Lei, Wu Gang, Li Baifeng, Zhang Jialin,
소속 상세정보
 ( Zhang Chengshuo ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Fu Dazhi ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Wang Fengshan ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Zhong Xinping ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Yang Lei ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Wu Gang ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Li Baifeng ) - China Medical University First Hospital Department of Hepatobiliary Surgery
 ( Zhang Jialin ) - China Medical University First Hospital Department of Hepatobiliary Surgery

Abstract


Purpose: Oxidized cellulose is available in many forms, but manufactured using either a regenerated or non-regenerated process. In this study, we evaluated the effects of 2 different hemostatic agents for the treatment of local bleeding in patients undergoing hepatic resection.

Methods: This was a monocentric, parallel-group, randomized, and controlled clinical trial to compare oxidized regenerated cellulose gauze (ORCG) with oxidized non-regenerated cellulose gauze (ONRCG) in patients undergoing hepatectomy. The primary endpoint was the time to hemostasis at the target bleeding site. The secondary endpoints were the postoperative drainage volume on the first 2 days after surgery and the hospital stay.

Results: There was no significant difference between the ORCG and ONRCG groups in time to hemostasis from column analysis (238.8 ± 121.6 seconds vs. 193.7 ± 85.3 seconds, P = 0.068), and there were no differences in the rates of hemostatic success between the 2 groups at 120 seconds (18.4% vs. 24.3%; odds ratio [OR], 0.703; 95% confidence interval [CI], 0.231?2.136) and 300 seconds (71.1% vs. 89.2%; OR, 0.298; 95% CI, 0.085?1.041). However, the ONRCG group was superior to the ORCG group in hemostasis according to the survival analysis (log-rank test, P = 0.044). Moreover, there were also no significant differences between the 2 groups in postoperative drainage volume on the first 2 days (P = 0.436, P = 0.381) and hospital stay (P = 0.537, P = 0.200).

Conclusion: ONRCG was not inferior to ORCG as a hemostatic agent in patients undergoing liver resection.

키워드

Hepatectomy; Hemostasis; Oxidized cellulose; Surgicel; Traumastem

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