Overview

The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
A randomized controlled study is performed to address the question of whether the topical application of a novel fibrin sealant, Evicel (Johnson & Johnson Wound Management, Ethicon, Somerville, NJ) in patient undergoing total knee replacement (TKR) reduce the perioperative blood loss and the need for allogenic blood transfusion compared to a control group. We hypothesize that fibrin sealant decrease the drop in post-operative hemoglobin level after total knee replacement.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Milan
Treatments:
Fibrin Tissue Adhesive
Criteria
Inclusion Criteria:

- patient scheduled for TKR

- written informed consent

- diagnosis of osteoarthritis

Exclusion Criteria:

- previous intervention on the same Knee (except for meniscectomy)

- Hb pre-operative level lower than 12g/dl for man and 11g/dl for woman

- Anticoagulation therapy or any anti-aggregate treatment not suspended at least 4 days
before surgery