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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320514
Recruitment Status : Unknown
Verified March 2011 by Nguyen, Davis B., M.D..
Recruitment status was:  Recruiting
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
Baxter BioScience
Information provided by:
Nguyen, Davis B., M.D.

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.

Condition or disease Intervention/treatment
Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant Drug: Fibrin Sealant (Artiss)

Study Type : Observational
Estimated Enrollment : 10 participants
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
Study Start Date : December 2010
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Group/Cohort Intervention/treatment
Fibrin Sealant (Artiss) Drug: Fibrin Sealant (Artiss)

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Responsible Party: Davis B Nguyen, M.D. Identifier: NCT01320514     History of Changes
Other Study ID Numbers: Endoscopic Browlift
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Fibrin Tissue Adhesive