CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)biological
Likely dose
Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)from record
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Search/NCT00708071
NCT00708071Phase 2Completed
CompareCT.gov

An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Rhytidectomy

Baxter Healthcare Corporation·interventional·Posted Jul 2, 2008·Updated Oct 23, 2012

In Brief

A Phase 2 clinical trial evaluating Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) for Facial Rhytidectomy (Face-lift). Completed, enrolled 45 participants across 6 sites.

Detailed Summary

The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in participants undergoing a rhytidectomy (face-lift).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytidectomy (Face-lift)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18 years ago

Interventions

Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)biological

Each subject received fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated containing synthetic aprotinin (FS VH S/D 4 ) to one side of the face. The dosing volume to be applied is 0.02 mL/cm2 to 0.04 mL/cm2. The study product will be applied to the subcutaneous plane in both the neck and the face area. The product will be applied using the spray device provided by the sponsor. (The other side of the face will be treated using standard of care.)