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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01320514
Enrollment
10
Registered
2011-03-22
Start date
2010-12-31
Completion date
2011-05-31
Last updated
2011-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

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.

Interventions

DRUGFibrin Sealant (Artiss)

Sponsors

Baxter BioScience
CollaboratorINDUSTRY
Nguyen, Davis B., M.D.
Lead SponsorINDIV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Comparison of ecchymosis and edema30 days

Secondary

MeasureTime frame
Resolution of ecchymosis and edema, incidence of hematoma/seroma30 days

Countries

United States

Contacts

Primary ContactDavis B Nguyen, MD
nguyendavisb@yahoo.com310 550 0288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026