Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

N/AEnrolling By InvitationNCT07132892

Jeffrey M. Kenkel6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tissue Adhesion

Interventions

Galaflex Lite ScaffoldDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Eligibility Criteria Inclusion Criteria 1. Healthy adults 18-80 years of age 2. Planned/scheduled rhytidectomy at UT Southwestern with the study doctor 3. Willing to return for follow up visits and undergo study evaluations Exclusion Criteria 1. Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc) 2. Individuals who have significant scarring on the test area 3. Individuals with a disorder to negatively affect wound healing

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Ultrasonography

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

Time frame: 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

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

Secondary Outcomes

Histological Assessment

Tissue will be obtained, for research purposes, to assess histological evaluation assessment. Change from baseline will be calculated to assess change

Time frame: Baseline, Month 6 and Month 12

Instron Biomedical Testing

The Instron device measures the mechanical properties of the tissue.

Time frame: Baseline, Month 6 and Month 12

Face-Q: Satisfaction with Facial Appearance

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

Time frame: Baseline, Month 6 and Month 12

Face-Q: Satisfaction with Outcome

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.

Data from ClinicalTrials.gov

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