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Enrolling by Invitation

NCT Number: NCT07132892

Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

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.

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Key information

Conditions

Tissue Adhesion Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

This is a prospective study designed to follow six (6) qualified and consenting adults, 18-80 years of age scheduled for an elective rhytidectomy with the Principal Investigator (PI). Subjects will be evaluated at baseline, month 1, month 6 and month 12. The effects of the study device will be analyzed at all follow up visits through clinical/3D photography, non-invasive skin assessments and subject/physician questionnaires. The PI will be collecting tissue samples during their surgical procedure, month 6 and month 12 visits. Histopathology will be completed on the collected sample to assess changes of the tissue after the subjects rhytidectomy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Ultrasonography

    Time frame: Baseline, Month 3 and Month 6 and Month 12

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

  2. Bio-mechanical Tissue Characterization

    Time frame: Baseline, Month 3 and Month 6 and Month 12

    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

Secondary outcomes

  1. Histological Assessment

    Time frame: Baseline, Month 6 and Month 12

    Tissue will be obtained, for research purposes, to assess histological evaluation assessment.

    Change from baseline will be calculated to assess change

  2. Instron Biomedical Testing

    Time frame: Baseline, Month 6 and Month 12

    The Instron device measures the mechanical properties of the tissue.

  3. Face-Q: Satisfaction with Facial Appearance

    Time frame: Baseline, Month 6 and Month 12

    scale that measures a patient's overall satisfaction with how their face looks. It assesses things like symmetry, harmony, proportion, and vitality.

    A scale that measures a patient's overall satisfaction with how their face looks. It assesses things like symmetry, harmony, proportion, and vitality.

    A score from 0 to 100, where a higher score indicates a better outcome or greater satisfaction

  4. Face-Q: Satisfaction with Outcome

    Time frame: Baseline, Month 6 and Month 12

    A series of positively worded questions to ask patients directly how they feel about the outcome.

    A score from 0 to 100, where a higher score indicates greater satisfaction with the outcome.

Sponsors and collaborators

Lead sponsor

Jeffrey M. Kenkel

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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