Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00713596

Purpose

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.

Condition	Intervention
Recovery Time Bruising	Drug: Fibrinogen Procedure: Septorhinoplasty Procedure: Taping after septorhinoplasty. Procedure: Cast applied to the nose after nasal surgery

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Subject, Caregiver, Investigator), Factorial Assignment, Safety/Efficacy Study
Official Title:	The Use of Fibrin Sealant During Septorhinoplasty: A Randomized Controlled Trial Evaluating Short and Long Term Benefits

Resource links provided by NLM:

MedlinePlus related topics: Bruises Edema Surgery

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	July 2008

Arms	Assigned Interventions
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 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.
1: 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 One time application of 0.5cc to 2.0cc of fibrinogen following surgery. 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.
2: 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 One time application of 0.5cc to 2.0cc of fibrinogen following surgery. Procedure: Septorhinoplasty Septorhinoplasty to correct nasal deviation. Procedure: Taping after septorhinoplasty. Simple taping over the nose following nasal surgery.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713596

Contacts

Contact: Nicole Tombers

(507) 538-1392

tombers.nicole@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55904
Contact: Tombers tombers.nicole@mayo.edu
Principal Investigator: Oren Friedman, M.D.
Sub-Investigator: Rizwan Siwani, MBBS

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Friedman Oren, M.D.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

Bhanot S, Alex JC. Current applications of platelet gels in facial plastic surgery. Facial Plast Surg. 2002 Feb;18(1):27-33. Review.

Responsible Party:	Mayo Clinic ( Oren Friedman )
Study ID Numbers:	06-009614
Study First Received:	July 9, 2008
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00713596 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Nasal Surgery
Septorhinoplasty
fibrin glue
fibrinogen

Swelling
fibrin
tisseel

Study placed in the following topic categories:

Contusions
Fibrin Tissue Adhesive
Edema
Hemostatics

Additional relevant MeSH terms:

Coagulants
Fibrin Tissue Adhesive
Therapeutic Uses

Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on September 03, 2009