Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
6 participants
INTERVENTIONAL
2025-12-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Healthy Participants
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
2. Individuals who have significant scarring on the test area
3. Individuals with a disorder to negatively affect wound healing
18 Years
80 Years
ALL
Yes
Sponsors
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Jeffrey M. Kenkel
OTHER
Responsible Party
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Jeffrey M. Kenkel
Chairman and Professor
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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STU20251603
Identifier Type: -
Identifier Source: org_study_id
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