The novel use and feasibility of hemostatic oxidized regenerated cellulose agent (SurgiGuard & REG;): multicenter retrospective study

Abstract

Background: SurgiGuard (R) is an absorbent hemostatic agent based on oxidized regenerated cellulose. The efficacy, effects and safety of SurgiGuard (R) are equivalent to existing hemostatic agents in animal experiments. This study was designed to confirm that the use of SurgiGuard (R) alone is effective, safe and feasible compared to combination with other hemostatic methods.Methods: We retrospectively reviewed clinical data from 12 surgery departments in seven tertiary centers in South Korea nationwide. All surgeries were performed between January and December 2018. Results: A total of 807 patients were enrolled; 447 patients (55.4%) had comorbidities. The rate of major surgery (operative time & GE;4 hours) was 44% (n=355 patients). Regarding the type of SurgiGuard (R) used in surgery, more than 70% of minor surgeries used non-woven types. In major surgery, more than five SurgiGuards (R) were used in 7.3% (26 patients), and the proportion of co-usage (with four other hemostatic products) was 19.7% (70 patients). The effectiveness score was higher when SurgiGuard (R) was used alone in both major (5.3 & PLUSMN;0.5 vs. 5.1 & PLUSMN;0.6, P=0.048) and minor surgery (5.4 & PLUSMN;0.6 vs. 5.2 & PLUSMN;0.4, P<0.001). Seven patients had immediate re-bleeding, and all of them used SurgiGuard<(R)> and other products together. Nine patients reported adverse effects, such as abscess, bleeding, or leg swelling, but we found no direct correlation with SurgiGuard (R) .Conclusions: SurgiGuard (R) exhibited greater effectiveness when used alone. No direct adverse effects associated with SurgiGuard (R) use were reported, and SurgiGuard (R) had stable feasibility. Prospective comparative studies are needed in the future.