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

NCT01816282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-03-25

No results posted yet for this study

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.

Conditions

  • Total Knee Replacement
  • Primary Knee Arthroplasty
  • Osteoarthritis of the Knee

Interventions

DRUG

Evicel

Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-04-30
Completion
2012-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01816282 on ClinicalTrials.gov