At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
In Brief
A Phase 3 clinical trial evaluating Fibrocaps and Gelatin sponge for Mild or Moderate Surgical Bleeding. Completed, enrolled 721 participants across 48 sites in 4 countries.
Detailed Summary
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Study Details
Timeline
Interventions
Human fibrinogen and thrombin powder, for topical administration.
Absorbable gelatin sponge for topical administration.