Clinical Trial: Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Mayo Clinic

Current Primary Outcome: 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



Original Primary Outcome: 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. ]

Current Secondary Outcome: 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.


Original Secondary Outcome: 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. ]

Information By: Mayo Clinic

Dates:
Date Received: July 9, 2008
Date Started: July 2008
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016