Ann Surg Treat Res.  2021 Apr;100(4):193-199. 10.4174/astr.2021.100.4.193.

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

Affiliations
  • 1Department of Hepatobiliary Surgery, The First Hospital of China Medical University, Shenyang, China

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.

Keyword

Hepatectomy; Hemostasis; Oxidized cellulose; Surgicel; Traumastem
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