Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
Part of paid clinical trials in Dallas, Texas.
- Sponsor
- Jeffrey M. Kenkel
- Study ID
- NCT07132892
- Status
- Enrolling By Invitation
Conditions
- Tissue Adhesion
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- Galaflex Lite Scaffold — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Aug 2025
- Primary completion
- Jun 30, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 6 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Healthy ParticipantsHealthy subjects who received an elective rhytidectomy 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.
Primary Outcome Measure
Ultrasonography [ Time Frame: Baseline, Month 3 and Month 6 and Month 12 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | - |
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