NCT01320514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 22, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

November 30, 2010

Last Update Submit

March 19, 2011

Conditions

Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Outcome Measures

Primary Outcomes (1)

  • Comparison of ecchymosis and edema

    30 days

Secondary Outcomes (1)

  • Resolution of ecchymosis and edema, incidence of hematoma/seroma

    30 days

Study Arms (1)

Fibrin Sealant (Artiss)

Drug: Fibrin Sealant (Artiss)

Interventions

Fibrin Sealant (Artiss)DRUG
Fibrin Sealant (Artiss)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Davis B Nguyen, M.D.

Beverly Hills, California, 90212, United States

RECRUITING

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Davis B Nguyen, M.D.

    Davis B Nguyen, M.D.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davis B Nguyen, MD

CONTACT

310 550 0288nguyendavisb@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

November 30, 2010

First Posted

March 22, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 22, 2011

Record last verified: 2011-03

Locations

US(1)