NCT02235363

Brief Summary

In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments. For the intraoperative evaluation the tensiometer was applied and for the postoperative evaluation the FACE-Q applied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

September 4, 2014

Last Update Submit

May 3, 2018

Conditions

Keywords

face liftthread liftretaining ligamentV-Loc suturestensiometerFACE-Q

Outcome Measures

Primary Outcomes (1)

  • Revision or reoperation

    Checking whether revision was done by patients' need or not.

    3 and 6 months

Secondary Outcomes (5)

  • Suboptimal outcomes

    3 and 6 months

  • Asymmetry

    3 and 6 months

  • Scar revision

    3 and 6 months

  • Dimpling

    3 and 6 months

  • Stitch abscess

    3 and 6 months

Study Arms (1)

facelift

EXPERIMENTAL

In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.

Procedure: thread lift

Interventions

thread liftPROCEDURE

In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.

Also known as: suspension technique with V-Loc barbed sutures
facelift

Eligibility Criteria

Age23 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary case
  • secondary case

You may not qualify if:

  • wide scar tissue on face
  • allergy to foreign body(thread)
  • no skin excess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Plastic Surgery, Winners Clinic

Seoul, 135-893, South Korea

Location

Related Publications (1)

  • Sasaki GH, Cohen AT. Meloplication of the malar fat pads by percutaneous cable-suture technique for midface rejuvenation: outcome study (392 cases, 6 years' experience). Plast Reconstr Surg. 2002 Aug;110(2):635-54; discussion 655-7. doi: 10.1097/00006534-200208000-00042.

    PMID: 12142689BACKGROUND

Study Officials

  • CHEOLHWAN KIM, M.D.

    Winners Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 369 consecutive patients underwent the suture suspension technique, so called thread lift, using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively, with a mean of 34.3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

January 1, 2012

Primary Completion

December 31, 2016

Study Completion

May 31, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations