Tissue AdhesionNCT07132892
Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
A study testing Galaflex Lite Scaffold in people with Tissue Adhesion, run by Jeffrey M. Kenkel at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Adhesion
- What is being tested?
- Galaflex Lite Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study
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.
Read the 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.
- Conditions
- Tissue Adhesion
- Being tested
- Galaflex Lite Scaffold
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galaflex Lite ScaffoldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Galaflex Lite Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Ultrasonography will be used to evaluate the skin thickness and density for research purposes.
Measured: 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
Measured: Baseline, Month 3 and Month 6 and Month 12
Secondary outcomes (4)
Histological Assessment
Tissue will be obtained, for research purposes, to assess histological evaluation assessment.
Change from baseline will be calculated to assess change
Measured: Baseline, Month 6 and Month 12
Instron Biomedical Testing
The Instron device measures the mechanical properties of the tissue.
Measured: 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
Measured: 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.
Measured: Baseline, Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study procedure will be used to assess changes of the tissue.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey M. Kenkel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132892
- Sponsor's protocol ID
- STU20251603
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study
- ClinicalTrials.gov ID
- NCT07132892
- Acronym / sponsor ID
- STU20251603
- Conditions
- Tissue Adhesion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Jeffrey M. KenkelUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study procedure will be used to assess changes of the tissue.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Device: Galaflex Lite ScaffoldHealthy 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galaflex Lite ScaffoldThe 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 | Healthy Participants |
Primary outcome
Ultrasonography
Time frame: Baseline, Month 3 and Month 6 and Month 12
Ultrasonography will be used to evaluate the skin thickness and density for research purposes.
Bio-mechanical Tissue Characterization
Time frame: Baseline, Month 3 and Month 6 and Month 12
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galaflex Lite Scaffold in people with Tissue Adhesion, run by Jeffrey M. Kenkel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography (time frame: Baseline, Month 3 and Month 6 and Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.