Abstract

OBJECTIVE When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA). METHODS We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups. RESULTS The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of -13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups. CONCLUSIONS The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.

Abstract

INTRODUCTION The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effect for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 54 patients, with 26 patients in the intervention group (flowable hemostatic matrix) and 27 patients in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy (DP), POPF (33.3% vs. 92.3%, p = 0.004) and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) were more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use (p = 0.029) as an independent negative risk factor for POPF. CONCLUSIONS Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP.

Abstract

BACKGROUND The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effects for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 53 patients, of whom 26 patients were in the intervention group (flowable hemostatic matrix) and 27 patients were in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy, POPF (33.3% vs. 92.3%, p = 0.004), and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) was more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use as an independent negative risk factor for POPF, especially in cases of distal pancreatectomy (DP) (odds ratio 17.379, 95% confidential interval 1.453-207.870, p = 0.024). CONCLUSION Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP. Non-inferiority was demonstrated in the efficacy of preventing POPF in the intervention group compared to the control group.