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Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

This study has been terminated.
(Lead investigator moved to a new medical center; study was stopped when he left.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00713596
First received: July 9, 2008
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.


Condition Intervention
Recovery Time
Bruising
Drug: Fibrinogen
Procedure: Septorhinoplasty
Procedure: Taping after septorhinoplasty.
Procedure: Cast applied to the nose after nasal surgery
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Septorhinoplasty
Septorhinoplasty to correct nasal deviation.
Procedure: Taping after septorhinoplasty.
Simple taping over the nose following nasal surgery.
Procedure: Cast applied to the nose after nasal surgery
A molded cast will be placed on top of the nose following nasal surgery.
Other: Saline
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.
Drug: Fibrinogen
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
Other Name: Tisseel
Procedure: Septorhinoplasty
Septorhinoplasty to correct nasal deviation.
Procedure: Taping after septorhinoplasty.
Simple taping over the nose following nasal surgery.
Procedure: Cast applied to the nose after nasal surgery
A molded cast will be placed on top of the nose following nasal surgery.
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.
Drug: Fibrinogen
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
Other Name: Tisseel
Procedure: Septorhinoplasty
Septorhinoplasty to correct nasal deviation.
Procedure: Taping after septorhinoplasty.
Simple taping over the nose following nasal surgery.

Detailed Description:

Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713596

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55904
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Oren Friedman, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Oren Friedman, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00713596     History of Changes
Other Study ID Numbers: 06-009614
Study First Received: July 9, 2008
Results First Received: April 19, 2012
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Nasal Surgery
Septorhinoplasty
fibrin glue
fibrinogen
Swelling
fibrin
tisseel

ClinicalTrials.gov processed this record on November 25, 2014