An interventional study of Galaflex Lite Scaffold in Tissue Adhesion, sponsored by Jeffrey M. Kenkel. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Jeffrey M. Kenkel · Not applicable, Interventional, and Treatment
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.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's planned enrollment of 6 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →This is the only study on the registry with Jeffrey M. Kenkel as lead sponsor.
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Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
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.
Device: Galaflex 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.
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
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.
Time frame: Baseline, Month 6 and Month 12
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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