Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

Not Applicable

Not yet recruiting

• Conditions: Tissue Adhesion

• Registration Number: NCT07132892
• Lead Sponsor: Jeffrey M. Kenkel

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-12-01
• Primary Completion: 2026-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ultrasonography	Baseline, Month 3 and Month 6 and Month 12	Ultrasonography will be used to evaluate the skin thickness and density for research purposes.
Bio-mechanical Tissue Characterization	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 Outcome Measures

Name	Time	Method
Instron Biomedical Testing	Baseline, Month 6 and Month 12	The Instron device measures the mechanical properties of the tissue.
Face-Q: Satisfaction with Facial Appearance	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
Face-Q: Satisfaction with Outcome	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.
Histological Assessment	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