- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00713596
Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty
The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55904
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any patient over 18 years of age undergoing septorhinoplasty.
Exclusion Criteria:
- Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
SHAM_COMPARATOR: Control group
Septorhinoplasty with postoperative application of nasal taping and an external nasal cast.
The tape and cast will be left in place for one week.
No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline.
|
Septorhinoplasty to correct nasal deviation.
Simple taping over the nose following nasal surgery.
A molded cast will be placed on top of the nose following nasal surgery.
Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.
|
EXPERIMENTAL: Fibrinogen, tape, and cast
Septorhinoplasty will be performed.
At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site.
Approximately 0.5 cc to 2 cc of tissue sealant will be applied.
After closure, tape and cast will be applied and left in place for one week.
|
Septorhinoplasty to correct nasal deviation.
Simple taping over the nose following nasal surgery.
A molded cast will be placed on top of the nose following nasal surgery.
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
Other Names:
|
EXPERIMENTAL: Fibrinogen and tape
Septorhinoplasty will be performed.
At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied.
Nasal tape will be applied after closure.
|
Septorhinoplasty to correct nasal deviation.
Simple taping over the nose following nasal surgery.
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
Time Frame: 6 months post operative
|
ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied). NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem). Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose |
6 months post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire
Time Frame: 6 months postoperative
|
At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons.
The photos will be presented to the evaluators in a completely random fashion at a single session.
These photos will be graded at that time using the same questionnaire used by the operating surgeon.
The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.
|
6 months postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-009614
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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