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ENROLLING BY INVITATION
NCT07132892
NA

Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

Sponsor: Jeffrey M. Kenkel

View on ClinicalTrials.gov

Summary

The study is being conducted to objectively assess tissue changes following the use of P4HB in rhytidectomy to understand how the utilization of the surgical mesh may affect tissue mechanical strength and elasticity, wound healing, and scar formation dynamics.

Official title: Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-12-01

Completion Date

2027-12-31

Last Updated

2026-01-07

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Galaflex Lite Scaffold

The GalaFLEX LITE is a surgical mesh scaffold composed of poly-4-hydroxybutyrate (P4HB) developed to prolong strength retention and reinforce soft tissue in patients undergoing plastic and reconstructive surgery.

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States