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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Nguyen, Davis B., M.D..
Recruitment status was:  Recruiting
Baxter BioScience
Information provided by:
Nguyen, Davis B., M.D. Identifier:
First received: November 30, 2010
Last updated: March 19, 2011
Last verified: March 2011
The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.

Condition Intervention
Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant Drug: Fibrin Sealant (Artiss)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Nguyen, Davis B., M.D.:

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

Secondary Outcome Measures:
  • Resolution of ecchymosis and edema, incidence of hematoma/seroma [ Time Frame: 30 days ]

Estimated Enrollment: 10
Study Start Date: December 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fibrin Sealant (Artiss) Drug: Fibrin Sealant (Artiss)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects planned for endoscopic browlift; healthy female or male; age 18-75

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01320514

Contact: Davis B Nguyen, MD 310 550 0288

United States, California
Davis B Nguyen, M.D. Recruiting
Beverly Hills, California, United States, 90212
Contact: Davis B Nguyen, M.D.    310-550-0288   
Sponsors and Collaborators
Nguyen, Davis B., M.D.
Baxter BioScience
Principal Investigator: Davis B Nguyen, M.D. Davis B Nguyen, M.D.
  More Information

Responsible Party: Davis B Nguyen, M.D. Identifier: NCT01320514     History of Changes
Other Study ID Numbers: Endoscopic Browlift
Study First Received: November 30, 2010
Last Updated: March 19, 2011

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Fibrin Tissue Adhesive
Coagulants processed this record on September 21, 2017