A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

Phase 1

Completed

Conditions: General Surgery
Hemostasis

Interventions: Combination Product: sFilm-FS
Combination Product: TACHOSIL®

Registration Number: NCT04660721

Lead Sponsor: Sealantium Medical Ltd.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

Inclusion Criteria

Patients (males or females) aged ≥ 18 years old.
Patients requiring elective open hepatic surgery.
Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
Patients understanding the nature of the study and providing their informed consent prior to participation.
Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.

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

Exclusion Criteria

Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
Patients with a severe coagulopathy defined as INR > 2.0.
Patients with platelet count <50,000 x109 PLT/L at the screening.
Patients admitted to trauma surgery.
Transplant patients due to fulminant hepatic failure.
Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
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.
Patients suffering from claustrophobia.
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.
Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
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.
Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.

Intra-operative exclusion criteria:
Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
Patients having an active local infection in the anatomic surgical area.
Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
Patients with bleeding site in or near to foramina in bone.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sFilm-FS	sFilm-FS	-
TACHOSIL®	TACHOSIL®	-

Primary Outcome Measures

Name	Time	Method
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...	From visit 1 to visit 9 (an average of 6.5 months)	Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)
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	From visit 1 to visit 9 (an average of 6.5 months)	Safety will be assessed from randomization of patients until the last follow-up visit by measuring Body Temperature (°C)
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	From visit 1 to visit 9 (an average of 6.5 months)	Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)
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	From visit 1 to visit 9 (an average of 6.5 months)	Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Presence of Glucose)
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	From visit 1 to visit 9 (an average of 6.5 months)	Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Protein (g/L))
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.	Last Follow-Up Visit (Visit 9)	Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.

Secondary Outcome Measures

Name	Time	Method
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	Day of surgery	Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure
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	Day of surgery	Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)
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	Day of surgery	Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes
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	Day of surgery	Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.	From surgery, up to 6 months	Incidence of transfusion requirements in the 6 months follow-up period

Trial Locations

Locations (4): Medical University of Vienna, Department of Surgery Hepatobiliary Unit
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Vienna, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
🇦🇹
Linz, Austria
Washington University in St. Louis, School of Medicine, Department of Surgery
🇺🇸
Saint Louis, Missouri, United States
University Medical Center of Ljubljana, Division of Surgery
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Ljubljana, Slovenia