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Trials / Terminated

TerminatedNCT00713596

Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFibrinogenOne time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
PROCEDURESeptorhinoplastySeptorhinoplasty to correct nasal deviation.
PROCEDURETaping after septorhinoplasty.Simple taping over the nose following nasal surgery.
PROCEDURECast applied to the nose after nasal surgeryA molded cast will be placed on top of the nose following nasal surgery.
OTHERSalineApproximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.

Timeline

Start date
2008-07-01
Primary completion
2010-01-01
Completion
2010-01-01
First posted
2008-07-11
Last updated
2016-04-18
Results posted
2012-07-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00713596. Inclusion in this directory is not an endorsement.

Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty (NCT00713596) · Clinical Trials Directory