Thread Lift by Use of Retaining Ligaments

Minimal Invasive Surgery Clinical Trial

— TL  

Official title:

Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235363
• Other study ID #: Thread Lift
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: May 31, 2017

Study information

• Verified date: May 2018
• Source: Winners Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 369
• Est. completion date: May 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 76 Years

Eligibility

Inclusion Criteria:

• primary case

• secondary case

Exclusion Criteria:

• wide scar tissue on face

• allergy to foreign body(thread)

• no skin excess

Related Conditions & MeSH terms

• Face Lift
• Minimal Invasive Surgery
• Suspension Technique

Intervention

Procedure:
• thread lift
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.

Locations

Country	Name	City	State
Korea, Republic of	The Department of Plastic Surgery, Winners Clinic	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Winners Clinic

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision or reoperation	Checking whether revision was done by patients' need or not.	3 and 6 months
Secondary	Suboptimal outcomes	Checking whether patients were satisfied with the postoperative outcomes of their faces or not.	3 and 6 months
Secondary	Asymmetry	Comparing the degree of sagging of the right and left faces to see if there is any difference.	3 and 6 months
Secondary	Scar revision	Checking whether scar revision was done due to hypertrophic scar on the operative sites or not.	3 and 6 months
Secondary	Dimpling	Checking whether patients complained about dimpling on the operation sites of their faces or not.	3 and 6 months
Secondary	Stitch abscess	Checking whether the operative sites were infected or not.	3 and 6 months