Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for... | NCT01320514

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

NCT01320514

Sponsor

Nguyen, Davis B., M.D.

Status

Unknown status

Last Update Posted

Mar 22, 2011Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant

Interventions

Fibrin Sealant (Artiss)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

May 2011Estimated

Completion Date

May 2011Estimated

First Submitted Date

Nov 30, 2010

First Submission Date that Met QC Criteria

Mar 19, 2011

First Posted Date

Mar 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2011

Last Update Posted Date

Mar 22, 2011Estimated

Name	Class
Baxter BioScience	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Fibrin Sealant (Artiss)			Drug: Fibrin Sealant (Artiss)

Name	Type	Description	Arm Group Labels	Other Names
Fibrin Sealant (Artiss)	Drug		Fibrin Sealant (Artiss)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of ecchymosis and edema		30 days

Secondary Outcomes

Measure	Description	Time Frame
Resolution of ecchymosis and edema, incidence of hematoma/seroma		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Davis B Nguyen, MD	Contact	310 550 0288		nguyendavisb@yahoo.com

Overall Officials

Name	Affiliation	Role
Davis B Nguyen, M.D.	Davis B Nguyen, M.D.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Davis B Nguyen, M.D.	Recruiting	Beverly Hills	California	90212	United States

Intervention Browse Module

MeSH Terms

ID	Term
D015718	Fibrin Tissue Adhesive

Ancestor Terms

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided