Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
Phase 2
Completed
- Conditions
- Hemostatic TechniquesNephrectomy
- Interventions
- Biological: Fleece
- Registration Number
- NCT00598130
- Lead Sponsor
- OMRIX Biopharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I Fleece patients who will be treated in accordance with standard of care II Fleece patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
- Primary Outcome Measures
Name Time Method Proportion of successes at 10 minutes following randomization 10 minutes
- Secondary Outcome Measures
Name Time Method Proportion of successes at 5 minutes following randomization 5 minutes
Trial Locations
- Locations (4)
Meir MC
🇮🇱Kfar Saba, Israel
Sheaba MC
🇮🇱Tel-Aviv, Israel
Rabin MC
🇮🇱Tel Aviv, Israel
Bnei-Zion MC
🇮🇱Haifa, Israel