Evaluation Of Cloumella Strut Effect In Tip Rotation

Nose Deformities, Acquired Clinical Trial

Official title:

Evaluation of Cloumella Strut in Maintenance of Tip Rotation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467714
• Other study ID #: BS-181351
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2007
• Last updated: November 17, 2008
• Start date: February 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.

Description:

In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• RHINOPLASTIC PATIENTS

Exclusion Criteria:

• REVISION SURGERY,

• INCOMPLETE STRIP,

• FACIAL ANOMALY

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nose Deformities, Acquired

Intervention

Procedure:
• rhinoplasty
COLUMELLA STRUT PLACEMENT

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIP ROTATION		6 month after surgery	Yes
Secondary	TIP PROJECTION		6 month after surgery	Yes