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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
History of Changes

July 9, 2008
July 23, 2012
July 2008
January 2010   (final data collection date for primary outcome measure)
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
The patient questionnaire scores (ROE score, NOSE score, nose deformity score) and responses regarding bruising, swelling, and recovery time. [ Time Frame: 1 month post operative, and 6 months post operative. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00713596 on ClinicalTrials.gov Archive Site
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.
Assessment of the results of surgery by review of post operative photographs by the operating surgeon and 3 blinded reviewers. [ Time Frame: 1 months post operative and 6 months post operative. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty
The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Recovery Time
  • Bruising
  • 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.
  • Other: Saline
    Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.
  • 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.
    Interventions:
    • Procedure: Septorhinoplasty
    • Procedure: Taping after septorhinoplasty.
    • Procedure: Cast applied to the nose after nasal surgery
    • Other: Saline
  • 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.
    Interventions:
    • Drug: Fibrinogen
    • Procedure: Septorhinoplasty
    • Procedure: Taping after septorhinoplasty.
    • Procedure: Cast applied to the nose after 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.
    Interventions:
    • Drug: Fibrinogen
    • Procedure: Septorhinoplasty
    • Procedure: Taping after septorhinoplasty.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
January 2010
January 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00713596
06-009614
Yes
Oren Friedman, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Oren Friedman, M.D. Mayo Clinic
Mayo Clinic
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP