Hemostatic Techniques, Nephrectomy
Conditions
Keywords
Patients undergoing elective open partial nephrectomy surgery, Excision of a kidney
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.
Interventions
BIOLOGICALFleece
Fibrin Patch
Sponsors
OMRIX Biopharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of successes at 10 minutes following randomization | 10 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of successes at 5 minutes following randomization | 5 minutes |
Countries
Israel
Outcome results
None listed