PMID- 30303427 OWN - NLM STAT- MEDLINE DCOM- 20201228 LR - 20201228 IS - 1521-0553 (Electronic) IS - 0894-1939 (Linking) VI - 33 IP - 3 DP - 2020 Mar TI - 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. PG - 218-230 LID - 10.1080/08941939.2018.1489917 [doi] AB - 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 (T(4)) 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 T(4) 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 T(4) 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. FAU - Lakshman, Shankar AU - Lakshman S AD - Lotus Clinical Research, LLC, Pasadena, CA, USA. FAU - Aqua, Keith AU - Aqua K AD - Visions Clinical Research, Wellington, FL, USA. FAU - Stefanovic, Aleksandar AU - Stefanovic A AD - Clinic of Obstetrics and Gynecology, Clinical Center of Serbia, Belgrade, Serbia and Medical Faculty, University of Belgrade, Belgrade, Serbia. FAU - Djurdjevic, Srdjan AU - Djurdjevic S AD - Department of Obstetrics and Gynecology, Clinical Centar of Vojvodina, Novi Sad, Serbia. FAU - Nyirady, Peter AU - Nyirady P AD - Department of Urology, Semmelweis University, Budapest, Hungary. FAU - Osvath, Peter AU - Osvath P AD - Department of Gynaecology and Obstetrics, Kenezy Hospital, Debrecen, Hungary. FAU - Davis, Ronald AU - Davis R AD - Wake Forest University Baptist Medical Center, Winston-Salem, NC, USA. FAU - Bullock, Arnold AU - Bullock A AD - Urologic Surgery, Washington University School of Medicine, St Louis, MO, USA. FAU - Chen, Junliang AU - Chen J AD - Grifols Bioscience Research Group, Barcelona, Spain. FAU - Ibanez, Julia AU - Ibanez J AD - Grifols Bioscience Research Group, Barcelona, Spain. FAU - Barrera, Gladis AU - Barrera G AD - Grifols Bioscience Research Group, Barcelona, Spain. FAU - Navarro-Puerto, Jordi AU - Navarro-Puerto J AD - Grifols Bioscience Research Group, Barcelona, Spain. CN - Fibrin Sealant Grifols in Soft Tissue Surgery Study Clinical Investigation Group AD - Collaborators listed at end of manuscript. LA - eng PT - Clinical Trial, Phase III PT - Equivalence Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20181010 PL - United States TA - J Invest Surg JT - Journal of investigative surgery : the official journal of the Academy of Surgical Research JID - 8809255 RN - 0 (Cellulose, Oxidized) RN - 0 (Fibrin Tissue Adhesive) RN - 0 (Hemostatics) RN - 82347-53-3 (Surgicel) SB - IM MH - Adult MH - Aged MH - Blood Loss, Surgical/*prevention & control/statistics & numerical data MH - Cellulose, Oxidized/*administration & dosage/adverse effects MH - Female MH - Fibrin Tissue Adhesive/*administration & dosage/adverse effects MH - Hemostasis, Surgical/adverse effects/*methods MH - Hemostatics/*administration & dosage/adverse effects MH - Humans MH - Male MH - Middle Aged MH - Prospective Studies MH - Single-Blind Method MH - Surgical Procedures, Operative/*adverse effects MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Fibrin Sealant Grifols OT - Surgicel OT - hemostasis OT - plasma-derived OT - soft tissue surgery EDAT- 2018/10/12 06:00 MHDA- 2020/12/29 06:00 CRDT- 2018/10/11 06:00 PHST- 2018/10/12 06:00 [pubmed] PHST- 2020/12/29 06:00 [medline] PHST- 2018/10/11 06:00 [entrez] AID - 10.1080/08941939.2018.1489917 [doi] PST - ppublish SO - J Invest Surg. 2020 Mar;33(3):218-230. doi: 10.1080/08941939.2018.1489917. Epub 2018 Oct 10.