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Search / Trial NCT07132892

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.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported