A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
NCT ID: NCT04660721
Last Updated: 2025-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
33 participants
INTERVENTIONAL
2021-05-12
2023-05-18
Brief Summary
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Detailed Description
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Many products are not as effective in the presence of active and/or brisk bleeding since the lack of sufficient adhesion strength allows forceful bleeding to simply "float" the products away from the bleeding tissue, prior to the achievement of full hemostasis.
The Study investigates a new product, sFilm-FS, aimed to help the control of body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sFilm-FS
sFilm-FS
sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
TACHOSIL®
TACHOSIL®
TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
Interventions
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sFilm-FS
sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
TACHOSIL®
TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
Eligibility Criteria
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Inclusion Criteria
2. Patients requiring elective open hepatic surgery.
3. Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
4. Patients understanding the nature of the study and providing their informed consent prior to participation.
5. Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.
Exclusion Criteria
2. Patients with a severe coagulopathy defined as INR \> 2.0.
3. Patients with platelet count \<50,000 x109 PLT/L at the screening.
4. Patients admitted to trauma surgery.
5. Transplant patients due to fulminant hepatic failure.
6. Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
7. Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
8. Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers.
9. Patients suffering from claustrophobia.
10. Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
11. Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
12. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
13. Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
14. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
15. Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
16. Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
17. Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
18. Patients having an active local infection in the anatomic surgical area.
19. Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
20. Patients with bleeding site in or near to foramina in bone.
18 Years
ALL
No
Sponsors
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Sintesi Research Srl
INDUSTRY
Home Medics Consulting Ltd.
UNKNOWN
Sealantium Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Orgad Laub, Professor
Role: STUDY_DIRECTOR
Sealantium Medical Ltd.
Locations
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Washington University in St. Louis, School of Medicine, Department of Surgery
St Louis, Missouri, United States
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, , Austria
Medical University of Vienna, Department of Surgery Hepatobiliary Unit
Vienna, , Austria
University Medical Center of Ljubljana, Division of Surgery
Ljubljana, , Slovenia
Countries
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References
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Spotnitz WD. Fibrin sealant: past, present, and future: a brief review. World J Surg. 2010 Apr;34(4):632-4. doi: 10.1007/s00268-009-0252-7.
Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
Spotnitz WD, Burks S. Hemostats, sealants, and adhesives: components of the surgical toolbox. Transfusion. 2008 Jul;48(7):1502-16. doi: 10.1111/j.1537-2995.2008.01703.x. Epub 2008 Apr 14.
Seyednejad H, Imani M, Jamieson T, Seifalian AM. Topical haemostatic agents. Br J Surg. 2008 Oct;95(10):1197-225. doi: 10.1002/bjs.6357.
Sundaram CP, Keenan AC. Evolution of hemostatic agents in surgical practice. Indian J Urol. 2010 Jul;26(3):374-8. doi: 10.4103/0970-1591.70574.
Fok M, Ah-Chong AK, Cheng SW, Wong J. Comparison of a single layer continuous hand-sewn method and circular stapling in 580 oesophageal anastomoses. Br J Surg. 1991 Mar;78(3):342-5. doi: 10.1002/bjs.1800780323.
Scherock TR, Clifford MD, Deveney W, Eneglebert J, Dunphy MD, Factors contributing to leakage of colonic anastomoses, Annual meeting of the Southern Surgical Association Boca Raton, Florida, 1972
Lane DA, Philippou H, Huntington JA. Directing thrombin. Blood. 2005 Oct 15;106(8):2605-12. doi: 10.1182/blood-2005-04-1710. Epub 2005 Jun 30.
Tanaka KA, Taketomi T, Szlam F, Calatzis A, Levy JH. Improved clot formation by combined administration of activated factor VII (NovoSeven) and fibrinogen (Haemocomplettan P). Anesth Analg. 2008 Mar;106(3):732-8, table of contents. doi: 10.1213/ane.0b013e318163fc76.
Wheat JC, Wolf JS Jr. Advances in bioadhesives, tissue sealants, and hemostatic agents. Urol Clin North Am. 2009 May;36(2):265-75, x. doi: 10.1016/j.ucl.2009.02.002.
Hung A, Garcia-Tsao G. Acute kidney injury, but not sepsis, is associated with higher procedure-related bleeding in patients with decompensated cirrhosis. Liver Int. 2018 Aug;38(8):1437-1441. doi: 10.1111/liv.13712. Epub 2018 Feb 24.
Randall D, Fenner J, Gillott R, Ten Broek R, Strik C, Spencer P, Bardhan KD. A Novel Diagnostic Aid for Detection of Intra-Abdominal Adhesions to the Anterior Abdominal Wall Using Dynamic Magnetic Resonance Imaging. Gastroenterol Res Pract. 2016;2016:2523768. doi: 10.1155/2016/2523768. Epub 2016 Jan 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HEM-01-17
Identifier Type: -
Identifier Source: org_study_id
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