Tissue Adhesion
Conditions
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.
Interventions
DEVICEGalaflex Lite Scaffold
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.
Sponsors
Jeffrey M. Kenkel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study procedure will be used to assess changes of the tissue.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed