NCT02224001

Brief Summary

For achieving the desired refinements in Asian patients, sufficient septal cartilage must be needed for the ieal tip projection and lengthening of the nose by the septal extension graft, columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many cases having insufficient septal cartilages in Asian augmentation rhinoplasty. The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

6.4 years

First QC Date

August 21, 2014

Last Update Submit

September 11, 2014

Conditions

Keywords

tip plastyseptal cartilage

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Serious and Non-Serious Adverse Events

    * tip deviation : 1 case * low tip projection : 1 case

    six months

Study Arms (1)

Asian rhinoplasty, septal cartilage

EXPERIMENTAL

A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.

Procedure: The Flag Technique

Interventions

A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.

Asian rhinoplasty, septal cartilage

Eligibility Criteria

Age17 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary case
  • secondary case

You may not qualify if:

  • septal cartilage harvested state
  • congenital anomaly in septal cartilage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Plastic Surgery, Winners Clinic

Gangnamgu, Seoul, 135-893, South Korea

Location

Related Publications (1)

  • 1.Toriumi, D.M. Augmentation rhinoplasty with autologous cartilage grafting. In Park JI, Toriumi, D.M., eds. Asian Facial Cosmetic Surgery. Philadelphia: Saunders-Elsvier, 2007. 2.Toriumi, D.M. Autologous grafts are worth the extra time. Arch Otolaryngol Head Neck Surg 126:562-564, 2000. 3.Toriumi, D.M., DeRosa J. The Asian nose. In R. J. Rohrich, W. P. Jr. Adams, and J. Ahmad, J. P. Gunter (Eds.), Dallas Rhinoplasty: Nasal Surgery by the Masters, Vol 2, 3rd Ed. St. Louise: Quality Medical, 2014. Pp. 1226-1229. 4.Byrd , H.S., Burt, J.D., Andochick, S., et al. Septal extension grafts: a method for controlling tip projection and shape. Plast Reconstr Surg 100:999-1010, 1997. 5.Rohrich R.J., Kurkjian T.J., Hoxworth R.E., et al. The effect of the columellar strut graft on the nasal tip position in primary rhinoplasty. Plast Reconstr Surg 130:926-932, 2012. Erratum in Plast Reconstr Surg 130:1399, 2012.

    BACKGROUND

Study Officials

  • CHEOLHWAN KIM, MD

    Winners Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

January 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations