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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 because the information has not been verified recently.
Verified March 2011 by Nguyen, Davis B., M.D..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baxter BioScience
Information provided by:
Nguyen, Davis B., M.D.
ClinicalTrials.gov Identifier:
NCT01320514
First received: November 30, 2010
Last updated: March 19, 2011
Last verified: March 2011
History of Changes
  Purpose

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:

MedlinePlus related topics: Edema Endoscopy
U.S. FDA Resources

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

Primary Outcome Measures:
  • Comparison of ecchymosis and edema [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resolution of ecchymosis and edema, incidence of hematoma/seroma [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects planned for endoscopic browlift; healthy female or male; age 18-75

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320514

Contacts
Contact: Davis B Nguyen, MD 310 550 0288 nguyendavisb@yahoo.com

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

No publications provided

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

Additional relevant MeSH terms:
Ecchymosis
Edema
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
 Signs and Symptoms
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013