Recruiting

Fibrin Sealant

Sponsor:

Nguyen, Davis B., M.D.

Code:

NCT01320514

Conditions

Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Fibrin Sealant (Artiss)

Study Details

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.

Conditions

Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Study ID

NCT01320514

Start date

Dec, 2010

Status verified date

Mar, 2011

Completion date

May, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Fibrin Sealant (Artiss)

Interventions

Fibrin Sealant (Artiss)

Primary outcome measure

  • Comparison of ecchymosis and edema [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Davis B Nguyen, M.D.

Recruiting

Beverly Hills, California, United States, 90212

Contacts

More Information

Sponsor

Nguyen, Davis B., M.D.

Last update posted

Mar 22, 2011

Last verified

Mar, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nguyen, Davis B., M.D. on 2011-03-22.