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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Participants | Experimental | Healthy subjects who received an elective rhytidectomy 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonography | Ultrasonography will be used to evaluate the skin thickness and density for research purposes. | 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 | Baseline, Month 3 and Month 6 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Histological Assessment | Tissue will be obtained, for research purposes, to assess histological evaluation assessment. Change from baseline will be calculated to assess change | Baseline, Month 6 and Month 12 |
| Instron Biomedical Testing |
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Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Study procedure will be used to assess changes of the tissue.
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The Instron device measures the mechanical properties of the tissue.
| 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 | 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. | Baseline, Month 6 and Month 12 |