1.
Efficacy and Safety of a Thrombin-Containing Collagen-based Haemostatic Agent in Spinal Surgery: A Randomized Clinical Trial
Park SM, Kang DR, Lee JH, Jeong YH, Shin DA, Yi S, Ha Y, Kim KN
World neurosurgery. 2021
Abstract
OBJECTIVE When common haemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local haemostatic agents are used. We aimed to evaluate the haemostatic efficacy and safety of CollaStat® (Dalim Tissen Co. Ltd., Korea), a novel thrombin-containing collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal® (Baxter Healthcare, USA). METHODS We performed a randomised 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 haemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the two groups. RESULTS The haemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal® since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal® was greater than the pre-specified non-inferiority margin of -13%. There were no statistically significant differences at the 5% level in haemostasis time, number of haemostatic agents used, hospitalisation period, and amount of drainage between the two groups. Also, there was no incidence of medical device-related serious adverse events (SAEs) or adverse events (AEs) in both groups. CONCLUSION The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal®. Therefore, CollaStat® can be safely and effectively used in spinal surgery.
2.
Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: A randomized clinical trial
Park Y, Ko JH, Kang DR, Lee JH, Hwang DW, Lee JH, Lee W, Kwon J, Park SN, Song KB, et al
Annals of hepato-biliary-pancreatic surgery. 2021;25(Suppl 1):S371
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.
3.
Effect of Flowable Thrombin-Containing Collagen-Based Hemostatic Matrix for Preventing Pancreatic Fistula after Pancreatectomy: A Randomized Clinical Trial
Park Y, Ko JH, Kang DR, Lee JH, Hwang DW, Lee JH, Lee W, Kwon J, Park SN, Song KB, et al
Journal of clinical medicine. 2020;9(10)
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.