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Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

Primary Purpose

Recovery Time, Bruising

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fibrinogen
Septorhinoplasty
Taping after septorhinoplasty.
Cast applied to the nose after nasal surgery
Saline
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recovery Time focused on measuring Nasal Surgery, Septorhinoplasty, fibrin glue, fibrinogen, Swelling, fibrin, tisseel

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control group

Fibrinogen, tape, and cast

Fibrinogen and tape

Arm Description

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 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 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.

Outcomes

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
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
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.

Full Information

First Posted
July 9, 2008
Last Updated
March 18, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00713596
Brief Title
Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty
Official Title
The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Lead investigator moved to a new medical center; study was stopped when he left.
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recovery Time, Bruising
Keywords
Nasal Surgery, Septorhinoplasty, fibrin glue, fibrinogen, Swelling, fibrin, tisseel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Fibrinogen, tape, and cast
Arm Type
Experimental
Arm Description
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.
Arm Title
Fibrinogen and tape
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fibrinogen
Other Intervention Name(s)
Tisseel
Intervention Description
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
Intervention Type
Procedure
Intervention Name(s)
Septorhinoplasty
Intervention Description
Septorhinoplasty to correct nasal deviation.
Intervention Type
Procedure
Intervention Name(s)
Taping after septorhinoplasty.
Intervention Description
Simple taping over the nose following nasal surgery.
Intervention Type
Procedure
Intervention Name(s)
Cast applied to the nose after nasal surgery
Intervention Description
A molded cast will be placed on top of the nose following nasal surgery.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
6 months post operative
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren Friedman, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55904
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

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Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

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