Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

Mayo Clinic

Status: Terminated

Conditions: Bruising; Recovery Time

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00713596

06-009614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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25 participants in 3 patient groups

Control group

Sham Comparator group

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.

Treatment:

Procedure: Cast applied to the nose after nasal surgery

Other: Saline

Procedure: Septorhinoplasty

Procedure: Taping after septorhinoplasty.

Fibrinogen, tape, and cast

Experimental group

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.

Treatment:

Procedure: Cast applied to the nose after nasal surgery

Drug: Fibrinogen

Procedure: Septorhinoplasty

Procedure: Taping after septorhinoplasty.

Fibrinogen and tape

Experimental group

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.

Treatment:

Drug: Fibrinogen

Procedure: Septorhinoplasty

Procedure: Taping after septorhinoplasty.