By InvitationNot Applicable

Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

United States6 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

Ultrasonography

Timeframe: Baseline, Month 3 and Month 6 and Month 12

Bio-mechanical Tissue Characterization

Timeframe: Baseline, Month 3 and Month 6 and Month 12

Trial details

NCT IDNCT07132892

SponsorJeffrey M. Kenkel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Tissue Adhesion trials