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

Abstract

Background: SurgiGuard® is an absorbent hemostatic agent based on oxidized regenerated cellulose. The efficacy, effects and safety of SurgiGuard® are equivalent to existing hemostatic agents in animal experiments. This study was designed to confirm that the use of SurgiGuard® 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 ≥4 hours) was 44% (n=355 patients). Regarding the type of SurgiGuard® used in surgery, more than 70% of minor surgeries used non-woven types. In major surgery, more than five SurgiGuards® 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® was used alone in both major (5.3±0.5 vs. 5.1±0.6, P=0.048) and minor surgery (5.4±0.6 vs. 5.2±0.4, P<0.001). Seven patients had immediate re-bleeding, and all of them used SurgiGuard® and other products together. Nine patients reported adverse effects, such as abscess, bleeding, or leg swelling, but we found no direct correlation with SurgiGuard®. Conclusions: SurgiGuard® exhibited greater effectiveness when used alone. No direct adverse effects associated with SurgiGuard® use were reported, and SurgiGuard® had stable feasibility. Prospective comparative studies are needed in the future.