Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy

Jeffrey M. Kenkel

Status: Invitation-only

Conditions: Tissue Adhesion

Treatments: Device: Galaflex Lite Scaffold

Study type: Interventional

Funder types: Other

Identifiers

NCT07132892

STU20251603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Healthy Participants

Experimental group

Description:

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.

Treatment:

Device: Galaflex Lite Scaffold