Superficial Musculoaponeurotic System (SMAS) Procedure
Conditions
Keywords
plastic surgery
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.
Interventions
None listed
Sponsors
Tepha, Inc.
C. R. Bard
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Satisfaction | 1 year | Investigator satisfaction will be judged by ease of product use, successful reinforcement, and total time for procedure to be completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 1 year | Patient satisfaction will be judged by the difference between pre- and post-surgery answers to Quality of Life questionnaires. |
Countries
United States
Outcome results
None listed