A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery

a Lotus Clinical Research, LLC , Pasadena , CA , USA. b Visions Clinical Research , Wellington , FL , USA. c Clinic of Obstetrics and Gynecology , Clinical Center of Serbia , Belgrade , Serbia and Medical Faculty , University of Belgrade , Belgrade , Serbia. d Department of Obstetrics and Gynecology , Clinical Centar of Vojvodina , Novi Sad , Serbia. e Department of Urology , Semmelweis University , Budapest , Hungary. f Department of Gynaecology and Obstetrics , Kenezy Hospital , Debrecen , Hungary. g Wake Forest University Baptist Medical Center , Winston-Salem , NC , USA. h Urologic Surgery , Washington University School of Medicine , St Louis , MO , USA. i Grifols Bioscience Research Group , Barcelona , Spain. i Grifols Bioscience Research Group , Barcelona , Spain. i Grifols Bioscience Research Group , Barcelona , Spain. i Grifols Bioscience Research Group , Barcelona , Spain. j Collaborators listed at end of manuscript.

Journal of Investigative Surgery : the Official Journal of the Academy of Surgical Research. 2018;:1-13.
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Abstract
BACKGROUND/PURPOSE Rapid hemostasis, an essential prerequisite of good surgical practice during surgical bleeding, including soft tissue open surgery, often requires adjunctive treatment. We evaluated the safety and hemostatic effectiveness of a human plasma-derived fibrin sealant (FS Grifols) in soft tissue open surgery. METHODS Patients with moderate soft tissue bleeding during open, urologic, gynecologic or general surgery were studied. The trial consisted of a preliminary phase (to familiarize investigators with the technique for FS Grifols application and the intraoperative procedures required by the clinical protocol) and a primary phase: in both phases, patients were randomized 1:1 to FS Grifols or Surgicel((R)). The primary efficacy endpoint, based on analysis of subjects in the primary phase of the study, was to evaluate whether FS Grifols was non-inferior to Surgicel((R)) in achieving hemostasis, based on the proportion of subjects in both treatment groups who achieved hemostasis at the target bleeding site (TBS) by 4 min (T4) following the start of treatment application. Safety assessments included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests, viral markers, and immunogenicity. RESULTS A total of 224 subjects were randomized (primary phase): FS Grifols (N = 116), Surgicel((R)) (N = 108). The 95% CI at T4 for the ratio of the proportion of patients achieving hemostasis in the two treatment groups was 1.064 (0.934, 1.213), indicating non-inferiority for FS Grifols vs. Surgicel((R)). The rate of hemostasis at the TBS by T4 in both phases of the study was higher in the FS Grifols treatment group (preliminary phase: 90.2%; primary phase: 82.8%) than in the Surgicel((R)) treatment group (preliminary phase: 78.8%; primary phase: 77.8%). Overall, reported AEs were as expected in surgical patients and were similar between the two treatment groups. CONCLUSIONS This study shows the non-inferiority in time to hemostasis of FS Grifols vs. Surgicel as an adjunct to hemostasis in patients undergoing soft tissue open surgery, and a similar rate of AEs.
Study details
Language : English
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