Dissector Assisted Malar Elevation for Rhytidoplasty (DAME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
LYDIA MASAKO FERREIRA, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00925158
First received: June 18, 2009
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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 Intervention
Aging
Premature Aging
Procedure: Dissector Assisted Malar Elevation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-randomized Clinical Trial for Evaluation of the Dissector Assisted Malar Elevation in Videoendoscopic Rhytidoplasty.

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Digital photogrammetry [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical instrument (DAME)
Surgical dissector instrument created to malar elevation.
Procedure: Dissector Assisted Malar Elevation
Malar dissector - Surgical instrument for video endoscopic rhytidoplasty.
Other Names:
  • Face
  • Rejuvenation
  • Rhytidoplasty
  • Video-Assisted Surgery
  • Malar fat pad
  • Image Processing
  • Computer-Assisted
  • Malar dissector
  • Dissector Assisted Malar Elevation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • white and non-white
  • premature facial aging

Exclusion Criteria:

  • diabetes
  • arterial hypertension
  • any previous facial aesthetic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925158

Locations
Brazil
Hospital São Paulo - UNIFESP
São Paulo, Brazil, 04023-002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Lydia M Ferreira, M.D., PhD. Plastic Surgery Division - Professor. Surgery Department - Chairwoman and Head.
  More Information

Additional Information:
Publications:
Responsible Party: LYDIA MASAKO FERREIRA, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00925158     History of Changes
Other Study ID Numbers: CEP-UNIFESP 1515/07
Study First Received: June 18, 2009
Last Updated: July 23, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Rhytidoplasty
Video-Assisted Surgery
Surgical instruments
Dissection
Innovative therapies
Face
Aging
Premature aging
Rejuvenation

Additional relevant MeSH terms:
Aging, Premature
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014