Face LiftTLNCT02235363
Thread Lift by Use of Retaining Ligaments
A study testing thread lift in people with Face Lift and Suspension Technique, run by Winners Clinic at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 23 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Face Lift, Suspension Technique, Minimal Invasive Surgery
- What is being tested?
- thread lift
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2012to 31 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- primary case
- secondary case
Who cannot join
- wide scar tissue on face
- allergy to foreign body(thread)
- no skin excess
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Department of Plastic Surgery, Winners Clinic
Seoul, 135-893
About this study
Official title: Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q
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.
Read the 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.
- Conditions
- Face Lift, Suspension Technique, Minimal Invasive Surgery
- Being tested
- thread lift
- Keywords
- face lift, thread lift, retaining ligament, V-Loc sutures, tensiometer, FACE-Q
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thread liftProcedure or surgery
Also called suspension technique with V-Loc barbed sutures
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: thread lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision or reoperation
Checking whether revision was done by patients' need or not.
Measured: 3 and 6 months
Secondary outcomes (5)
Suboptimal outcomes
Checking whether patients were satisfied with the postoperative outcomes of their faces or not.
Measured: 3 and 6 months
Asymmetry
Comparing the degree of sagging of the right and left faces to see if there is any difference.
Measured: 3 and 6 months
Scar revision
Checking whether scar revision was done due to hypertrophic scar on the operative sites or not.
Measured: 3 and 6 months
Dimpling
Checking whether patients complained about dimpling on the operation sites of their faces or not.
Measured: 3 and 6 months
Stitch abscess
Checking whether the operative sites were infected or not.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start1 Jan 2012
- Primary completion31 Dec 2016
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Face LiftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winners Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHEOLHWAN KIM, M.D., Principal investigator, Winners Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235363
- Sponsor's protocol ID
- Thread Lift
- Acronym
- TL
- Status last verified
- May 2018
- First submitted
- 4 Sep 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/00006534-200208000-00042.
PubMed 12142689
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q
- ClinicalTrials.gov ID
- NCT02235363
- Acronym / sponsor ID
- TL / Thread Lift
- Conditions
- Face Lift, Suspension Technique, Minimal Invasive Surgery
- Keywords
- face lift, thread lift, retaining ligament, V-Loc sutures, tensiometer, FACE-Q
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Winners ClinicUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| facelift | Experimental | Procedure: thread liftIn 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. |
Who may qualify
- Ages
- 23 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary case
- secondary case
Key exclusion criteria (3 listed)
- wide scar tissue on face
- allergy to foreign body(thread)
- no skin excess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thread liftAlso: suspension technique with V-Loc barbed suturesIn 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 or surgery | facelift |
Primary outcome
Revision or reoperation
Time frame: 3 and 6 months
Checking whether revision was done by patients' need or not.
5 secondary outcomes
Suboptimal outcomes
Time frame: 3 and 6 months
Asymmetry
Time frame: 3 and 6 months
Scar revision
Time frame: 3 and 6 months
Dimpling
Time frame: 3 and 6 months
Stitch abscess
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 12142689Sasaki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHEOLHWAN KIM, M.D. principal investigator
Winners Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thread lift in people with Face Lift and Suspension Technique, run by Winners Clinic at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revision or reoperation (time frame: 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.