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

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.

Comparison of Efficacy and Safety of Non-Regenerated and Regenerated Oxidized Cellulose Based Fibrous Haemostats

“…Moreover, there were also no significant differences between the 2 groups in postoperative drainage volume on the first 2 days and hospital stay (9). So far, all these published clinical data comparing the effectiveness of ORC and ONRC involved knitted haemostats (18). Given the current trend of fibrous haemostats, which are produced by a technology different from knitted forms, it was good to compare the effectiveness of fibrous haemostats ORC and ONRC.…”

“…The vast majority of published works were performed with haemostats based on ORC (2)(3)(4)(5)(6)(7)(8)(9). Only few papers describe the effect of ONRC haemostatic gauze (10)(11)(12)(13)(14) or felt (15)(16)(17) and only one published work compares the effect of ORC and ONRC knitted gauze in a larger group of patients (18). The works published so far show that ONRC has a similar or even superior effect (10,18).…”

A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus

“…For most other surgeries, the resection surfaces are sutured. Therefore, most studies on hemostatic agents have been conducted in patients undergoing hepatic resection [ 9 10 11 12 ]. Among hemostatic agents, physical polymeric agents such as cellulose, gelatin, starch, or collagen form a matrix at the site of bleeding which activates the extrinsic coagulation cascade and serves as a starting point for clot formation [ 13 ].…”