U.S. Study of Fibrocaps in Surgical Hemostasis
| Status: | Archived |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | July 2011 |
A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocapsâ„¢ and Gelatin Sponge (USP) in Surgical Hemostasis
The purpose of this study is to characterize the safety and hemostatic activity of topical
Fibrocaps in surgical patients when control of mild to moderate bleeding by standard
surgical techniques is ineffective and/or impractical.
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative
efficacy and safety trial in 60 subjects undergoing spinal surgery or peripheral vascular
surgery, (including peripheral artery bypass and arteriovenous graft formation for
hemodialysis). Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam
on the day of surgery.
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