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

NCT ID: NCT01320514

Last Updated: 2011-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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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

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Conditions

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Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fibrin Sealant (Artiss)

Fibrin Sealant (Artiss)

Intervention Type DRUG

Interventions

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Fibrin Sealant (Artiss)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baxter BioScience

INDUSTRY

Sponsor Role collaborator

Nguyen, Davis B., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Davis B Nguyen, M.D.

Principal Investigators

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Davis B Nguyen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Davis B Nguyen, M.D.

Locations

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Davis B Nguyen, M.D.

Beverly Hills, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Davis B Nguyen, MD

Role: CONTACT

310 550 0288

Facility Contacts

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Davis B Nguyen, M.D.

Role: primary

310-550-0288

Other Identifiers

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Endoscopic Browlift

Identifier Type: -

Identifier Source: org_study_id

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