Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin SealantNCT01320514
Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift
An observational study of Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant, run by Nguyen, Davis B., M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant
- What is being tested?
- Fibrin Sealant (Artiss)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects planned for endoscopic browlift; healthy female or male; age 18-75
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Davis B Nguyen, M.D.
Beverly Hills, California, 90212
Davis B Nguyen, M.D., 310-550-0288, nguyendavisb@yahoo.com
About this study
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
The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.
- Being tested
- Fibrin Sealant (Artiss)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant (Artiss)Drug
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Sealant (Artiss) | Not described Receives: Drug: Fibrin Sealant (Artiss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ecchymosis and edema
Measured: 30 days
Secondary outcomes (1)
Resolution of ecchymosis and edema, incidence of hematoma/seroma
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin SealantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nguyen, Davis B., M.D.
- Collaborators
- Baxter BioScience
- Investigators
- Davis B Nguyen, M.D., Principal investigator, Davis B Nguyen, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320514
- Sponsor's protocol ID
- Endoscopic Browlift
- Status last verified
- Mar 2011
- First submitted
- 30 Nov 2010
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01320514
- Acronym / sponsor ID
- Endoscopic Browlift
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nguyen, Davis B., M.D.
- Collaborators
- Baxter BioScience
- Study start
- Dec 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealant (Artiss) | – | Drug: Fibrin Sealant (Artiss) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects planned for endoscopic browlift; healthy female or male; age 18-75
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant (Artiss) | Drug | Fibrin Sealant (Artiss) |
Primary outcome
Comparison of ecchymosis and edema
Time frame: 30 days
1 secondary outcome
Resolution of ecchymosis and edema, incidence of hematoma/seroma
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davis B Nguyen, M.D. principal investigator
Davis B Nguyen, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant, run by Nguyen, Davis B., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davis B Nguyen, MD (310 550 0288, nguyendavisb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ecchymosis and edema (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011.