Dissector Assisted Malar Elevation for Rhytidoplasty

NCT00925158 | Unknown

• 1 other identifier: CEP-UNIFESP 1515/07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Premature Aging

Keywords

Rhytidoplasty; Video-Assisted Surgery; Surgical instruments; Dissection; Innovative therapies; Face; Aging; Premature aging; Rejuvenation

Outcome Measures

Primary Outcomes (1)

• Digital photogrammetry

  12 months

Study Arms (1)

Surgical instrument (DAME)

EXPERIMENTAL

Surgical dissector instrument created to malar elevation.

Procedure: Dissector Assisted Malar Elevation

Interventions

Dissector Assisted Malar Elevation PROCEDURE

Malar dissector - Surgical instrument for video endoscopic rhytidoplasty.

Also known as: Face, Rejuvenation, Rhytidoplasty, Video-Assisted Surgery, Malar fat pad, Image Processing, Computer-Assisted, Malar dissector

Surgical instrument (DAME)

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• white and non-white
• premature facial aging

You may not qualify if:

• diabetes
• arterial hypertension
• any previous facial aesthetic therapy

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital São Paulo - UNIFESP

São Paulo, São Paulo, 04023-002, Brazil

Location

Related Publications (1)

• Ferreira LM, Horibe EK. Understanding the finger-assisted malar elevation technique in face lift. Plast Reconstr Surg. 2006 Sep;118(3):731-40. doi: 10.1097/01.prs.0000233050.10568.66.

  PMID: 16932185 BACKGROUND

MeSH Terms

Conditions

Aging, Premature; Facies

Interventions

Rejuvenation; Rhytidoplasty; Video-Assisted Surgery

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Therapeutics; Cosmetic Techniques; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Lydia M Ferreira, M.D., PhD.

  Plastic Surgery Division - Professor. Surgery Department - Chairwoman and Head.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 19, 2009
• Study Start: December 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

BR (1)