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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02235363
Other study ID # Thread Lift
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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