Dissector Assisted Malar Elevation for Rhytidoplasty (DAME)
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|ClinicalTrials.gov Identifier: NCT00925158|
Recruitment Status : Unknown
Verified July 2012 by LYDIA MASAKO FERREIRA, Federal University of São Paulo.
Recruitment status was: Active, not recruiting
First Posted : June 19, 2009
Last Update Posted : July 24, 2012
BACKGROUND: Endoscopy was first used in plastic surgery for the treatment of frontal rhytides. This minimally invasive approach allows the treatment of frontal wrinkles using a practical procedure that does not directly interfere with the frontalis muscle, acting only on its antagonists.
It is also possible to treat the middle third of the face, but these evolutions depends on special surgical instruments. Videoendoscopic approach in rhytidoplasty have been improved by new devices and surgical instruments.
The mid third of the face can be treated in different ways. Zygomatic projection can be achieved by the use of the Dissector Assisted Malar Elevation (DAME) procedure.
AIM: Evaluate the zygomatic projection achieved by DAME in videoendoscopic rhytidoplasties.
METHODS: 30 non-white female patients, 30 to 59 years old, will be submitted to videoendoscopic rhytidoplasty with malar elevation by the DAME. Pre- and post-operative facial appearance will be evaluated by digital photogrammetry.
|Condition or disease||Intervention/treatment||Phase|
|Aging Premature Aging||Procedure: Dissector Assisted Malar Elevation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Non-randomized Clinical Trial for Evaluation of the Dissector Assisted Malar Elevation in Videoendoscopic Rhytidoplasty.|
|Study Start Date :||December 2007|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
Experimental: Surgical instrument (DAME)
Surgical dissector instrument created to malar elevation.
Procedure: Dissector Assisted Malar Elevation
Malar dissector - Surgical instrument for video endoscopic rhytidoplasty.
- Digital photogrammetry [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925158
|Hospital São Paulo - UNIFESP|
|São Paulo, Brazil, 04023-002|
|Principal Investigator:||Lydia M Ferreira, M.D., PhD.||Plastic Surgery Division - Professor. Surgery Department - Chairwoman and Head.|