Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant
Conditions
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.
Interventions
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of ecchymosis and edema | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of ecchymosis and edema, incidence of hematoma/seroma | 30 days |
Countries
United States