The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborator: Ethicon, Inc.
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

Exclusion Criteria:

• Known allergies to human blood products.

• History of bleeding disorders.

• Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.

• Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)

• Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.