ClinicalTrials.gg
Status unknownNCT01320514Updated Mar 22, 2011

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

An observational study in Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant, sponsored by Nguyen, Davis B., M.D.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-22.

Sponsored by Nguyen, Davis B., M.D. · Observational

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

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03

In context

Ecchymosis

38 studies on the registry are indexed under Ecchymosis; 6 are open to participants now.

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Lead sponsor

This is the only study on the registry with Nguyen, Davis B., M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects planned for endoscopic browlift, subjects who read, understand and sign the written , healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
10 participants (estimated)

Groups and cohorts

  • Fibrin Sealant (Artiss)

    Drug: Fibrin Sealant (Artiss)

Interventions

06

What researchers measure

Primary outcomes

  1. Comparison of ecchymosis and edema

    Time frame: 30 days

Secondary outcomes

  1. Resolution of ecchymosis and edema, incidence of hematoma/seroma

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Davis B Nguyen, M.D.
    Beverly Hills, California 90212, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2010, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2010
First posted
Mar 22, 2011
Start
Dec 2010
Primary completionEst.
May 2011
CompletionEst.
May 2011
Last update
Mar 22, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01320514
Lead sponsor
Nguyen, Davis B., M.D.
Collaborators
Baxter BioScience
First posted
Mar 22, 2011
Start date
Dec 2010
Primary completion
May 2011 (estimated)
Completion
May 2011 (estimated)
Last update
Mar 22, 2011

Study contacts

Davis B Nguyen, MD
Contact
nguyendavisb@yahoo.com
310 550 0288
Davis B Nguyen, M.D.
principal investigator · Davis B Nguyen, M.D.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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