Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

OMRIX Biopharmaceuticals30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemostatic Techniques Nephrectomy

Interventions

FleeceBIOLOGICAL

Fibrin Patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Bnei-Zion MC

Haifa, Israel

Meir MC

Kfar Saba, Israel

Rabin MC

Tel Aviv, Israel

Sheaba MC

Tel Aviv, Israel

Outcomes

Primary Outcomes

Proportion of successes at 10 minutes following randomization

Time frame: 10 minutes

Secondary Outcomes

Proportion of successes at 5 minutes following randomization

Time frame: 5 minutes

Data from ClinicalTrials.gov

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