NCT01320514UnknownNot Applicable
A Randomized, Controlled Study to Evaluate Safety and Efficacy of Fibrin Sealant VH S/D 4 S-APR (Artiss) for Tissue Adherence and Hemostasis and To Improve Wound Healing in Subjects Undergoing Endoscopic Browlift
Nguyen, Davis B., M.D.1 site in 1 country10 target enrollmentStarted: December 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Comparison of ecchymosis and edema
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Fibrin Sealant (Artiss)
Intervention: Fibrin Sealant (Artiss) (Drug)
Outcomes
Primary Outcomes
Comparison of ecchymosis and edema
Time Frame: 30 days
Secondary Outcomes
- Resolution of ecchymosis and edema, incidence of hematoma/seroma(30 days)
Investigators
Study Sites (1)
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