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

Sponsor

Sealantium Medical Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04660721

Collaborator

Sintesi Research Srl (Industry)

Enrollment

Locations

Arms

18.7

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemostasis General Surgery	Combination Product: sFilm-FS Combination Product: TACHOSIL®	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sFilm-FS	Combination Product: sFilm-FS sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
Active Comparator: TACHOSIL®	Combination Product: TACHOSIL® TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Arm

Intervention/Treatment

Experimental: sFilm-FS

Combination Product: sFilm-FS

sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.

Active Comparator: TACHOSIL®

Combination Product: TACHOSIL®

TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Outcome Measures

Primary Outcome Measures

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 evaluation of the incidence of Treatment-Emergent Adverse Events [Through study completion, an average of 6 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 [Through study completion, an average of 6 months]
Vital signs (considered altogether): blood pressure (mmHg) heart rate (beats/min) temperature (°C) respiratory rate (breaths/min)
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 [Through study completion, an average of 6 months]
Physical examination:the detection of the number of patients with clinical abnormalities in different body areas
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 [Through study completion, an average of 6 months]
Urine analysis (considered altogether): specific gravity, pH, glucose, protein, blood, ketones, microscopic examination
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 [Through study completion, an average of 6 months]
Blood / coagulation parameters profiles (considered altogether): Hb, HC, MCH, MCHC, MCV, RBC, WBC, PLT, Fibrinogen, lactate, D-Dimer, AT, ESR, CRP, BUN, creatinine, uric acid, BIL, LDH, AST (SGOT), ALT (SGPT), Gamma-GT, Na, Ca, P, glucose, albumin, total protein
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 fibrin and thrombin [Through study completion, an average of 6 months]
Measurement of plasma levels of antibodies against human fibrinogen and human thrombin
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 evaluation of the incidence of signs of systemic inflammation [Through study completion, an average of 6 months]
Incidence of signs of systemic inflammation

Secondary Outcome Measures

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 time to Hemostasis from first product application [Day of surgery]
Time to Hemostasis from first product application (TTHP). Time to Hemostasis from patient randomization (TTHR) will be collected as well but will not be used as endpoint
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Exclusion Criteria:

Patients undergoing a re-operative procedure.
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 (ref. 11).
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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis, School of Medicine, Department of Surgery	Saint Louis	Missouri	United States	63100
2	Ordensklinikum Linz GmbH Barmherzige Schwestern	Linz		Austria	4010
3	Medical University of Vienna, Department of Surgery Hepatobiliary Unit	Vienna		Austria	1090
4	University Medical Center of Ljubljana, Division of Surgery	Ljubljana		Slovenia	1000