Clinical trial NCT02053831: GalaFlex Mesh in Facelift
Official title: GalaFlex Mesh in Facelift
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Musculoaponeurotic System (SMAS) Procedure
Keywords: plastic surgery
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Tepha, Inc.
First posted: 2014-02-04
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinics

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physician Satisfaction
timeFrame: 1 year
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Ponte Vedra Beach
country: United States
facility: Ponte Vedra Plastic Surgery
state: Florida
city: Chicago
country: United States
facility: The Few Institute for Aesthetic Plastic Surgery
state: Illinois
city: Chicago
country: United States
facility: Eye and Ear Institute
state: Illinois
Study officials:
affiliation: Chief Scientific Officer, Founder
name: Arikha Moses, Ph.D
role: STUDY_DIRECTOR
References: