Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Omrix Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Nephrectomy; Hemostatic Techniques

Treatments: Biological: Fleece

Study type: Interventional

Funder types: Industry

Identifiers

NCT00598130

MoH

FL-PN-002-IS

Details and patient eligibility

About

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective open partial nephrectomy
• Patients must be willing to participate in the study, and provide written informed consent

Exclusion criteria

• Patients with a tumor diameter greater than 4 cm
• Any additional surgical intervention other than partial nephrectomy
• Patients with only one functional kidney
• Patients with known intolerance to blood products or other components of the product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

I

Experimental group

Description:

patients who will be treated in accordance with standard of care

Treatment:

Biological: Fleece

II

Active Comparator group

Description:

patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Treatment:

Biological: Fleece