Beverly Hills, California 90212


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.


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.


Study is Available At:


Original ID:

Endoscopic Browlift


NCT ID:

NCT01320514


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nguyen, Davis B., M.D.


Oversight Authority:

United States: WIRB


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Davis B Nguyen, M.D.
Principal Investigator
Davis B Nguyen, M.D.
Primary Contact:Davis B Nguyen, MD
310 550 0288
nguyendavisb@yahoo.com

Study Dates

Start Date:December 2010
Completion Date:May 2011
Completion Type:Anticipated
Primary Completion Date:May 2011
Primary Completion Type:Anticipated
Verification Date:March 2011
Last Changed Date:March 19, 2011
First Received Date:November 30, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comparison of ecchymosis and edema
Time Frame:30 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Resolution of ecchymosis and edema, incidence of hematoma/seroma
Time Frame:30 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Fibrin Sealant (Artiss)
Arm Name:Fibrin Sealant (Artiss)

Study Arms

Study Arm Type:Other
Arm Name:Fibrin Sealant (Artiss)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Nguyen, Davis B., M.D.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Baxter BioScience

Samples and Retentions

Study Population: Subjects planned for endoscopic browlift; healthy female or male; age 18-75
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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