跳至主要内容
临床试验/NCT00925158
NCT00925158Unknown不适用

Non-randomized Clinical Trial for Evaluation of the Dissector Assisted Malar Elevation in Videoendoscopic Rhytidoplasty.

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Digital photogrammetry

研究概览

简要总结

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.

详细描述

THE NEW SURGICAL INSTRUMENT:

The dissector developed by the authors is a stainless steel instrument, 20 cm in length, 1 cm in diameter, with a cylindrical handle, and an articulated section 3 cm in length and 1cm in diameter at the distal end. When the most proximal end of the handle is rotated, the articulated section provides for angulation or articulation of the distal end portion with respect to the longitudinal axis of the instrument that is similar to the movements of a distal phalanx of a finger.

SURGICAL TECHNIQUE:

  1. Frontal Region: An incision line, 2 cm long, in the median sagittal plane and 1 cm from the hairline; an incision line, 2 cm long, parallel and 4 cm from the sagittal line, to the right and left sides;
  2. Temporal Region: An incision line, 3 cm long, 3 cm from the hairline, perpendicular to and bisected by a line traced from the margin of the nasal wing, passing by the lateral palpebral commissure and extending in the posterior direction, bilaterally.

Following, the hair was gathered into bundles to allow access to the skin markings, and held by latex rings, which were obtained by cross-sectional cuts through fingers of sterile latex surgical gloves.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 59 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • white and non-white
  • premature facial aging

排除标准

  • arterial hypertension
  • any previous facial aesthetic therapy

结局指标

主要结局

Digital photogrammetry

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

LYDIA MASAKO FERREIRA

MD, PhD

Federal University of São Paulo

研究点 (2)

Loading locations...

相似试验