Use of V-Loc Suture for Mid-face Lifting in Short-flap Rhytidectomy

Use of the V-Loc Suture for Mid-Face Lifting in Short-flap Rhytidectomy

This study will evaluate and measure the Vloc suture's ability to elevate the mid-face when using a short flap, short incision technique in during a traditional face-lift. The objective of this study is to assess the suture's potential in elevating the mid-face when a traditional Lifestyle facelift is performed. We hypothesize that the Vloc suture will elevate the mid-face more effectively when using a short flap, short incision technique on a traditional facelift.

Study Overview

• Status: Terminated
• Conditions: Use of the Vloc Suture; Elevation of the Mid-face
• Intervention / Treatment: Device: V-Loc Suture

Detailed Description

A total of 25 patients who are already receiving a traditional Lifestyle Lift will be asked to participate. Once the consent form has been signed by the patient, the facelift will be performed as scheduled and the Vloc suture will be added to the mid-face area. Each patient will be added to a database and their progress will be tracked with photos taken before, at 6 weeks, and at 6 months following the procedure. All data stored will be locked into a hard drive that can only be accessed by the research staff and the doctor. The text data will be used by research staff for reports and articles.

* you must already have purchased and scheduled a facelift procedure with Lifestyle Lift to participate in this trial. The addition of only the V-loc suture is at no cost.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87110
      • Lifestyle Lift

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are scheduled to receive a Lifestyle Lift will be asked to participate. The first 25 patients who have consented will be included into the study.

Exclusion Criteria:

• Any patient who is not able to receive a facelift for whatever reason, or who do not want a facelift will not be apart of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rhytidectomy with Covidien; 25 patients receiving a mid-face lift in short-flap rhytidectomy	Device: V-Loc Suture; Other Names: Covidien

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Elevation of the mid-face	Initial- 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
No Retention of Mid-face	initial-6 Months

Collaborators and Investigators

• Sponsor: Lifestyle Lift

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (ESTIMATE): December 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 20131586