Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

Bruising Clinical Trial

Official title:

The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713596
• Other study ID #: 06-009614
• Status: Terminated
• Phase: N/A
• First received: July 9, 2008
• Last updated: July 23, 2012
• Start date: July 2008
• Est. completion date: January 2010

Study information

• Verified date: July 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruising
• Recovery Time

Intervention

Drug:
• Fibrinogen
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.

Procedure:
• Septorhinoplasty
Septorhinoplasty to correct nasal deviation.
• Taping after septorhinoplasty.
Simple taping over the nose following nasal surgery.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	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	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	No

External Links

•   Mayo Clinic Clinical Trials