Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Galaflex Lite Scaffold.
- Who it may be relevant to
- Registry conditions: Tissue Adhesion. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study
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.
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
- 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.
Primary outcome measures
- Ultrasonography [Time frame: Baseline, Month 3 and Month 6 and Month 12]
- Bio-mechanical Tissue Characterization [Time frame: Baseline, Month 3 and Month 6 and Month 12]
Secondary outcome measures (4)
- Histological Assessment [Time frame: Baseline, Month 6 and Month 12]
- Instron Biomedical Testing [Time frame: Baseline, Month 6 and Month 12]
- Face-Q: Satisfaction with Facial Appearance [Time frame: Baseline, Month 6 and Month 12]
- Face-Q: Satisfaction with Outcome [Time frame: Baseline, Month 6 and Month 12]
Eligibility criteria
Eligibility Criteria
Inclusion criteria
- Healthy adults 18-80 years of age
- Planned/scheduled rhytidectomy at UT Southwestern with the study doctor
- Willing to return for follow up visits and undergo study evaluations
Exclusion criteria
- Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc)
- Individuals who have significant scarring on the test area
- Individuals with a disorder to negatively affect wound healing
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT07132892 · STU20251603