At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 200 enrolled
Drug / intervention
Evicel fibrin sealantdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery
In Brief
A Phase 4 clinical trial evaluating Evicel fibrin sealant for Osteoarthritis. Completed, enrolled 200 participants across 1 site.
Detailed Summary
Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
CollaboratorsEthicon, Inc.
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedNov 2010
Primary CompletionMar 2012
Study CompletionSep 2012
TodayJul 2026
First PostedNov 5, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.7 years ago
Interventions
Evicel fibrin sealantdrug
Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.