Clinical trial NCT04660721: A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
Official title: A Phase I/II, Randomized, Prospective, Controlled, Multi-center, Open-label, Two-arm Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Liver Bleeding During Elective Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemostasis
General Surgery
Keywords: Body fluid leakage
Liver
Parenchymal bleeding
Hepatic surgery
Fibrin sealant
Fibrin patch
Human Fibrinogen
Human Thrombin
Coagulation
Lead sponsor: Sealantium Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Sintesi Research Srl
name: Home Medics Consulting Ltd.
First posted: 2020-12-09
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.

Detailed description: Many products have been developed as adjuncts to hemostasis in bleeding situations where traditional methods such as suture, clips or energy-based coagulation are ineffective or impractical.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients (males or females) aged ≥ 18 years old.
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.

   Intra-operative inclusion criteria:
6. Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).

Exclusion Criteria:

1. Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
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.

    Intra-operative exclusion criteria:
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.

Primary outcomes:
measure: To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Detection of Antibodies Against Fibrinogen.
timeFrame: Last Follow-Up Visit (Visit 9)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
measure: To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles
timeFrame: From visit 1 to visit 9 (an average of 6.5 months)
Secondary outcomes:
measure: To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS
timeFrame: Day of surgery
measure: To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS
timeFrame: Day of surgery
measure: To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis
timeFrame: Day of surgery
measure: To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure
timeFrame: Day of surgery
measure: To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.
timeFrame: From surgery, up to 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis, School of Medicine, Department of Surgery
state: Missouri
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Barmherzige Schwestern
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Surgery Hepatobiliary Unit
city: Ljubljana
country: Slovenia
facility: University Medical Center of Ljubljana, Division of Surgery
Study officials:
affiliation: Sealantium Medical Ltd.
name: Orgad Laub, Professor
role: STUDY_DIRECTOR
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