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AgingDAMENCT00925158

Dissector Assisted Malar Elevation for Rhytidoplasty

A study testing Dissector Assisted Malar Elevation in people with Aging and Premature Aging, run by Federal University of São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 59 years, women only
Conditions the study is for
Aging, Premature Aging
What is being tested?
Dissector Assisted Malar Elevation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
Dec 2007to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 59 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • white and non-white
  • premature facial aging

Who cannot join

  • diabetes
  • arterial hypertension
  • any previous facial aesthetic therapy

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital São Paulo - UNIFESP

    São Paulo, São Paulo, 04023-002

Other trials in Brazil

About this study

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

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.

Read more

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.

Read the detailed description

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.

Skin antisepsis was performed with 0.2% aqueous chlorhexidine, followed by the placement of sterile surgical drapes, and retracing of the sagittal, parasagittal and temporal incision lines (described above) with methylene blue.

The right temporal incision was performed on the marked area, cutting through the skin and superficial temporal fascia, and exposing the deep temporal fascia. Following, the undermining of the temporal region surrounding the incision was carried out in the interfascial plane, under direct vision, to prepare the optical cavity. The dissection proceeded to the orbital and zygomatic regions, under endoscopic vision, using a rigid endoscope (Karl Storz, model 7230 BWA) 18cm in length, 4mm in diameter and with a 30-degree angle. The dissection continued until the medial zygomatic-temporal vein (also known as sentinel vein) was reached; a xenon light source (Karl Storz, model 20131501) was used to illuminate the optical cavity.

The zygomatic-temporal vein was previously cauterized with an endoscopic grasper (Karl Storz, model 50232 GG) and incised with scissors (Karl Storz, model 50231 GW) to allow dissection toward the lateral orbital rim. In this region, after passing the lateral palpebral ligament, the undermining ?) deepened, becoming subperiosteal on the zygomatic bone. The subperiosteal undermining ?) progressed along the whole inferior orbital rim up to its most medial portion, superior to the infraorbital nerve, to completely release the inferior orbital rim under endoscopic vision with the aid of an elevator (Karl Storz, model 50205s).

Using the same surgical instrumentation, a subcutaneous tunnel was created from the temporal incision towards the middle third of the face until the inferolateral limit of the orbicularis oculi muscle was reached. From this point, a blunt dissection of the malar fat pad was performed with the use of a dissector instrument, which had been developed for this purpose, as described by the author in 2004 and published in 2006. After blunt dissection, the malar fat pad was projected in the antero-superior direction by means of a suture in the zygomatic projection to restore the zygomatic contour and the anterior projection of the middle third of the face. The above procedures were then repeated on the contralateral hemiface.

The procedure was continued with the frontal incisions, which were previously described, by cutting through the skin to the periosteum (fig. 2). A subperiosteal dissection of the entire frontal region was performed to a distance of 1 cm above the eyebrow.

Under endoscopic vision, the dissection proceeded to the glabella, where the periosteum was incised with a sharp dissector to expose the bone insertions of the procerus, corrugator and depressor supercilii muscles. A thin dissector and an endoscopic grasper with a diathermy cable (unipolar high-frequency cord, model 26002 M, Karl Storz) were used in the myotomy and partial myectomy of these muscles. This periosteotomy started at the glabella region, and continued transversally toward the lateral end of the eyebrow in both sides, passing by the supratrochlear nerve, and reaching the supraorbital nerve, where it was interrupted to be continued in a latero-medial direction in the next surgical step.

The frontal and temporal undermining were united by the incision of the temporal ligament with a sharp dissector, exposing its most inferior portion, where the Hakme ligament is located. This ligament was incised with endoscopic scissors; this maneuver simultaneously released the lateral margin of the detached periosteum. At this level, the periosteotomy continues marginal to the orbital rim in a lateral-medial direction to the supraorbital nerve, which was identified and isolated. All fibrous adhesions of the body and tail of the eyebrow found in this path were dissected using a sharp dissector until the fibers of the palpebral portion of the orbicularis oculi muscle were reached at this level, completing the horizontal periosteotomy in its entire extension, the treatment of structures, and the undermining of the periorbital, frontal and temporal regions.

For the patients in the fixation group, the fixation points of the frontal flap were determined as the intersection point between the parasagittal line that passes through the transition of the lateral third with the two medial thirds of the eyebrow and the hairline. This point was called FEP (flap elevation point).

After attaching one end of a 2-0 nylon monofilament thread to the deep temporal fascia, a Casagrande needle was inserted at the FEP, penetrating the skin and periosteum, and transfixing the point. Following, the needle was directed to the deep temporal fascia at the fixation level. At this level, the other end of the nylon thread was passed through the hole of the Casagrande needle. The needle was pulled back to the FEP and, at this point, the periosteum was transfixed from depth to surface, up to the deep dermis. Then, the needle was returned to the depth, to a point located 0.5 cm medially, in order to fix the flap at the FEP level. The needle was directed to the sagittal incision, where once more it penetrated in the periosteum from depth to surface, externalizing the nylon thread. The same procedure was performed on the contralateral side. The two free ends of both nylon threads were tied together with a surgical knot at their emergence point along the sagittal plane with enough traction to elevate and fix the eyebrow to a position immediately superior to the superior orbital rim.

The incisions were closed with 4-0 monofilament nylon suture on a 2cm triangular needle; the detached site was drained by a closed vacuum system, with a drain tube (size 10) fixed to the sagittal incision and maintained for 48 hours. The skin was cleansed with 0.9% saline solution, tincture of benzoin was applied, and self-adhesive microporous tape (Micropore) was used and maintained for 7 days.

PHOTOGRAPHIC STANDARDIZATION:

Photographs were taken from all patients in a standardized manner, with respect to the equipment, camera positioning, lighting conditions, and positioning of the cephalic segment in relation to the Frankfurt plane. Photographs were taken in frontal view preoperatively and at 12 months postoperatively.

DIGITAL PHOTOGRAMMETRY:

Image analysis was done on a personal computer using the UTHSCSA ImageTool Version 3.0 software for Windows.

Digital photogrammetric measurements were made based on the anthropometric landmarks Endocathion (EN), which corresponds to the medial palpebral commissure, and Exocathion (EX), which corresponds to the lateral palpebral commissure.22-24 The distance between the EN-right and EN-left points (EN-EN distance) was measured. The length of a paramedian vertical line, connecting the intersection of the lateral extension of the EN-EN line with the EX point to the intersection of the EN-EN line with the outer margin of the eyebrow, which was denominated EB (eyebrow) or distance EX-EB, was also measured.

Based on the photographs, the Brow Position Index (BPI) was calculated for both the right (BPIR) and left (BPIL) sides. The BPI was defined as the ratio between the EN-EN (in pixels) and EX-EB (in pixels) distances multiplied by 100. Following, the difference (delta), in absolute value, between the preoperative BPI (BPI-pre) and 12month postoperative BPI (BPI-post) was calculated for both sides.

Being tested
Dissector Assisted Malar Elevation
Keywords
Rhytidoplasty, Video-Assisted Surgery, Surgical instruments, Dissection, Innovative therapies, Face, Aging, Premature aging, Rejuvenation
Medical subject headings
Aging, Premature, Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dissector Assisted Malar ElevationProcedure or surgery

    Also called Face, Rejuvenation, Rhytidoplasty, Video-Assisted Surgery

    Malar dissector - Surgical instrument for video endoscopic rhytidoplasty.

Study groups in NCT00925158
Study groupRoleWhat they receive
Surgical instrument (DAME)ExperimentalSurgical dissector instrument created to malar elevation.
Receives: Procedure: Dissector Assisted Malar Elevation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Digital photogrammetry

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2012 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00925158
Sponsor's protocol ID
CEP-UNIFESP 1515/07
Acronym
DAME
Status last verified
Jul 2012
First submitted
18 Jun 2009
Last updated
24 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16932185

Questions about this trial

What is this clinical trial studying?

A study testing Dissector Assisted Malar Elevation in people with Aging and Premature Aging, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digital photogrammetry (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.

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