Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift

• Conditions: Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant
• Interventions: Drug: Fibrin Sealant (Artiss)

• Registration Number: NCT01320514
• Lead Sponsor: Nguyen, Davis B., M.D.

Brief Summary

The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-30
• Study Start: 2010-12
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-19
• Last Update Submitted: 2011-03-19
• Study First Posted: 2011-03-22
• Last Update Posted: 2011-03-22
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements

Exclusion Criteria

• Subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrin Sealant (Artiss)	Fibrin Sealant (Artiss)	-

Primary Outcome Measures

Name	Time	Method
Comparison of ecchymosis and edema	30 days

Secondary Outcome Measures

Name	Time	Method
Resolution of ecchymosis and edema, incidence of hematoma/seroma	30 days

Trial Locations

Locations (1)

Davis B Nguyen, M.D.; 🇺🇸 Beverly Hills, California, United States