TL: Thread Lift by Use of Retaining Ligaments

• Sponsor: Winners Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02235363
• Collaborator: (none)
• Enrollment: 369
• Location: 1
• Arm: 1
• Actual Duration (Months): 65
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Face Lift; Suspension Technique; Minimal Invasive Surgery	Procedure: thread lift	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 369 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q
• Actual Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 31, 2016
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: facelift 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; 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.; Other Names: suspension technique with V-Loc barbed sutures

Outcome Measures

Primary Outcome Measures

1. Revision or reoperation [3 and 6 months]

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

Secondary Outcome Measures

1. Suboptimal outcomes [3 and 6 months]

   Checking whether patients were satisfied with the postoperative outcomes of their faces or not.

2. Asymmetry [3 and 6 months]

   Comparing the degree of sagging of the right and left faces to see if there is any difference.

3. Scar revision [3 and 6 months]

   Checking whether scar revision was done due to hypertrophic scar on the operative sites or not.

4. Dimpling [3 and 6 months]

   Checking whether patients complained about dimpling on the operation sites of their faces or not.

5. Stitch abscess [3 and 6 months]

   Checking whether the operative sites were infected or not.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 76 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• primary case

• secondary case

Exclusion Criteria:

• wide scar tissue on face

• allergy to foreign body(thread)

• no skin excess

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Department of Plastic Surgery, Winners Clinic	Seoul		Korea, Republic of	135-893

Sponsors and Collaborators

• Winners Clinic

Investigators

• Principal Investigator: CHEOLHWAN KIM, M.D., Winners Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Winners Clinic
• ClinicalTrials.gov Identifier: NCT02235363
• Other Study ID Numbers: Thread Lift
• First Posted: Sep 9, 2014
• Last Update Posted: May 11, 2018
• Last Verified: May 1, 2018

• Keywords provided by Winners Clinic: face lift; thread lift; retaining ligament; V-Loc sutures; tensiometer; FACE-Q

Study Results

No Results Posted as of May 11, 2018