Clinical trial NCT02235363: Thread Lift by Use of Retaining Ligaments
Official title: Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Face Lift
Suspension Technique
Minimal Invasive Surgery
Keywords: face lift
thread lift
retaining ligament
V-Loc sutures
tensiometer
FACE-Q
Lead sponsor: Winners Clinic
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 369
Sex: ALL
Minimum age (years): 23
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Retrospective analysis was performed on 369 consecutive patients undergoing the suture suspension technique between January of 2012 and December of 2015, 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. There are asymmetry(n=2), scar revision(n=1), revision(n=4), dimpling(n=1), suboptimal outcomes(n=9), and stitch abscess(n=1). The thread lift by use of the retaining ligaments with V-lock barbed sutures can be recommended as an alternative technique in the facelift.

Eligibility criteria: Inclusion Criteria:

* primary case
* secondary case

Exclusion Criteria:

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

Primary outcomes:
measure: Revision or reoperation
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Suboptimal outcomes
timeFrame: 3 and 6 months
measure: Asymmetry
timeFrame: 3 and 6 months
measure: Scar revision
timeFrame: 3 and 6 months
measure: Dimpling
timeFrame: 3 and 6 months
measure: Stitch abscess
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Department of Plastic Surgery, Winners Clinic
Study officials:
affiliation: Winners Clinic
name: CHEOLHWAN KIM, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.