Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

NCT07132892 | Enrolling By Invitation FDA Device

• 1 other identifier: STU20251603
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tissue Adhesion

Outcome Measures

Primary Outcomes (2)

• Ultrasonography

  Ultrasonography will be used to evaluate the skin thickness and density for research purposes.

  Baseline, Month 3 and Month 6 and Month 12

• Bio-mechanical Tissue Characterization

  BTC will be used to measure skins laxity, viscoelasticity deformation, stiffness, energy absorption, elasticity, and deformation values for research purposes. Change from baseline will be calculated to assess change

  Baseline, Month 3 and Month 6 and Month 12

Secondary Outcomes (4)

• Histological Assessment

  Baseline, Month 6 and Month 12

• Instron Biomedical Testing

  Baseline, Month 6 and Month 12

• Face-Q: Satisfaction with Facial Appearance

  Baseline, Month 6 and Month 12

• Face-Q: Satisfaction with Outcome

  Baseline, Month 6 and Month 12

Study Arms (1)

Healthy Participants

EXPERIMENTAL

Healthy 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.

Device: Galaflex Lite Scaffold

Interventions

Galaflex Lite Scaffold DEVICE

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.

Healthy Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults 18-80 years of age
• Planned/scheduled rhytidectomy at UT Southwestern with the study doctor
• Willing to return for follow up visits and undergo study evaluations

You may not qualify if:

• Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc)
• Individuals who have significant scarring on the test area
• Individuals with a disorder to negatively affect wound healing

Sponsors & Collaborators

• Jeffrey M. Kenkel: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman and Professor

Model Details: Study procedure will be used to assess changes of the tissue.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)