Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

NCT00713596 | Terminated Results DMC

• 1 other identifier: 06-009614
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery Time; Bruising

Keywords

Nasal Surgery; Septorhinoplasty; fibrin glue; fibrinogen; Swelling; fibrin; tisseel

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

  6 months postoperative

Study Arms (3)

Control group

SHAM COMPARATOR

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; Procedure: Taping after septorhinoplasty.; Procedure: Cast applied to the nose after nasal surgery; Other: Saline

Fibrinogen, tape, and cast

EXPERIMENTAL

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; Procedure: Septorhinoplasty; Procedure: Taping after septorhinoplasty.; Procedure: Cast applied to the nose after nasal surgery

Fibrinogen and tape

EXPERIMENTAL

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; Procedure: Septorhinoplasty; Procedure: Taping after septorhinoplasty.

Interventions

Fibrinogen DRUG

One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.

Also known as: Tisseel

Fibrinogen and tape; Fibrinogen, tape, and cast

Septorhinoplasty PROCEDURE

Septorhinoplasty to correct nasal deviation.

Control group; Fibrinogen and tape; Fibrinogen, tape, and cast

Taping after septorhinoplasty. PROCEDURE

Simple taping over the nose following nasal surgery.

Control group; Fibrinogen and tape; Fibrinogen, tape, and cast

Cast applied to the nose after nasal surgery PROCEDURE

A molded cast will be placed on top of the nose following nasal surgery.

Control group; Fibrinogen, tape, and cast

Saline OTHER

Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient over 18 years of age undergoing septorhinoplasty.

You may not qualify if:

• Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55904, United States

Location

MeSH Terms

Conditions

Contusions

Interventions

Fibrinogen; Fibrin Tissue Adhesive; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Fibrin; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Study was terminated due to principal investigator leaving the institution.

Results Point of Contact

• Title: Dr. Oren Friedman
• Organization: Mayo Clinic

507-538-1392

Study Officials

• Oren Friedman, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: April 18, 2016
• Results First Posted: July 24, 2012

Record last verified: 2016-03

Locations

US (1)