Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
Launched by JEFFREY M. KENKEL · Aug 12, 2025
Trial Information
Current as of September 10, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a special surgical mesh called Poly-4-Hydroxybutyrate (P4HB) used during facelift surgery (rhytidectomy). Researchers want to see how this mesh affects the strength and flexibility of the tissue, how well wounds heal, and how scars form after the surgery. The goal is to better understand if using this mesh can improve the overall results and recovery from facelift procedures.
Adults between 18 and 80 years old who are healthy and have a planned facelift surgery at UT Southwestern with the study doctor may be eligible to join. Participants will need to come back for follow-up visits so the research team can check how their tissue is healing and how the mesh is working. People with allergies to certain materials in the mesh, significant scarring in the surgery area, or conditions that affect healing won’t be able to take part. The study hasn’t started recruiting yet, but it aims to help improve future surgical outcomes for patients undergoing facelifts.
Gender
ALL
Eligibility criteria
- • Eligibility Criteria
- • Inclusion Criteria
- • 1. Healthy adults 18-80 years of age
- • 2. Planned/scheduled rhytidectomy at UT Southwestern with the study doctor
- • 3. Willing to return for follow up visits and undergo study evaluations
- • Exclusion Criteria
- • 1. Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc)
- • 2. Individuals who have significant scarring on the test area
- • 3. Individuals with a disorder to negatively affect wound healing
About Jeffrey M. Kenkel
Jeffrey M. Kenkel, MD, is a distinguished clinical trial sponsor and leading expert in the field of plastic surgery and aesthetic medicine. With extensive experience in both surgical and non-surgical aesthetic procedures, Dr. Kenkel is recognized for his commitment to advancing innovative treatments through rigorous clinical research. His work focuses on improving patient outcomes and safety, contributing significantly to the development and evaluation of new technologies and therapies within the aesthetic and reconstructive surgery domains.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported