GalaFlex Mesh in Facelift

In this post market study a resorbable mesh (GalaFLEX) will be used to reinforce the lifted and imbricated SMAS along the suture lines and spread the load of the SMAS along a greater surface area. GalaFLEX mesh is comprised of resorbable 4-hydroxybutyrate fibers.

Study Overview

• Status: Completed
• Conditions: Superficial Musculoaponeurotic System (SMAS) Procedure

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Florida
    • Ponte Vedra Beach, Florida, United States, 32083
      • Ponte Vedra Plastic Surgery
  • Illinois
    • Chicago, Illinois, United States, 60611
      • The Few Institute for Aesthetic Plastic Surgery
    • Chicago, Illinois, United States, 60612
      • Eye and Ear Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinics

Description

Inclusion Criteria:

• Subject is able to understand the risks and benefits of participating in the study and must be willing to sign and date the Informed Consent Form for this study approved by the Institutional Review Board (IRB.)
• Be at least 21 years of age.
• Be willing and able to comply with the requirements of the protocol.
• Be willing to refrain from participating in any other investigational interventional study while enrolled in this study.
• Female subjects must have a negative pregnancy test within the last 24 hours timeline and have no intentions of becoming pregnant during participation in the study, or be sterilized.

Exclusion Criteria:

• Subject is unwilling or unable to give written consent to participate in the investigation or unable to comply with the requirements of the protocol.
• Subject has known severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies.
• Subject has any serious skin disease, e.g., Eczema and psoriasis of the face, severe rosacea, scleroderma, local infections and severe acne.
• Subjects has diabetes, coagulation disorders, connective tissue disorders, lipodystrophy, or other serious systemic disease.
• Active herpes labialis
• Subject is infected with HIV and/or received or may receive immunosuppressive therapy over the course of the study (such as rheumatoid arthritis).
• Received any experimental drug or device within the previous three months.
• Known alcohol or drug abuser.
• Female subject who is pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study.
• Possesses any psychological condition, or is under treatment for any condition which, in the opinion of the Investigator and/or consulting physicians(s),would constitute an unwarranted risk.
• Presents with severe jowling or severe cervical skin redundancy.
• Subject is currently a smoker or is a prior smoker who quit in the last 12 months.
• Active abscess or infection
• Currently involved with claims for, or is accepting, workers compensation
• Currently engaged in medical malpractice litigation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Satisfaction	Investigator satisfaction will be judged by ease of product use, successful reinforcement, and total time for procedure to be completed.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction will be judged by the difference between pre- and post-surgery answers to Quality of Life questionnaires.	1 year

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Tepha, Inc.
• Investigators: Study Director: Arikha Moses, Ph.D, Chief Scientific Officer, Founder

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: plastic surgery
• Other Study ID Numbers: CP-1040