Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

NCT ID: NCT00713596

Last Updated: 2016-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Recovery Time Bruising

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

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.

Group Type SHAM_COMPARATOR

Septorhinoplasty

Intervention Type PROCEDURE

Septorhinoplasty to correct nasal deviation.

Taping after septorhinoplasty.

Intervention Type PROCEDURE

Simple taping over the nose following nasal surgery.

Cast applied to the nose after nasal surgery

Intervention Type PROCEDURE

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

Saline

Intervention Type OTHER

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

Fibrinogen, tape, and cast

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.

Group Type EXPERIMENTAL

Fibrinogen

Intervention Type DRUG

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

Septorhinoplasty

Intervention Type PROCEDURE

Septorhinoplasty to correct nasal deviation.

Taping after septorhinoplasty.

Intervention Type PROCEDURE

Simple taping over the nose following nasal surgery.

Cast applied to the nose after nasal surgery

Intervention Type PROCEDURE

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

Fibrinogen and tape

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.

Group Type EXPERIMENTAL

Fibrinogen

Intervention Type DRUG

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

Septorhinoplasty

Intervention Type PROCEDURE

Septorhinoplasty to correct nasal deviation.

Taping after septorhinoplasty.

Intervention Type PROCEDURE

Simple taping over the nose following nasal surgery.

Interventions

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Fibrinogen

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

Intervention Type DRUG

Septorhinoplasty

Septorhinoplasty to correct nasal deviation.

Intervention Type PROCEDURE

Taping after septorhinoplasty.

Simple taping over the nose following nasal surgery.

Intervention Type PROCEDURE

Cast applied to the nose after nasal surgery

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

Intervention Type PROCEDURE

Saline

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

Intervention Type OTHER

Other Intervention Names

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Tisseel

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oren Friedman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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06-009614

Identifier Type: -

Identifier Source: org_study_id

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