Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-28 @ 6:41 AM
Study NCT ID:
NCT07132892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study procedure will be used to assess changes of the tissue.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonography', 'timeFrame': 'Baseline, Month 3 and Month 6 and Month 12', 'description': 'Ultrasonography will be used to evaluate the skin thickness and density for research purposes.'}, {'measure': 'Bio-mechanical Tissue Characterization', 'timeFrame': 'Baseline, Month 3 and Month 6 and Month 12', 'description': 'BTC will be used to measure skins laxity, viscoelasticity deformation, stiffness, energy absorption, elasticity, and deformation values for research purposes.\n\nChange from baseline will be calculated to assess change'}], 'secondaryOutcomes': [{'measure': 'Histological Assessment', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'Tissue will be obtained, for research purposes, to assess histological evaluation assessment.\n\nChange from baseline will be calculated to assess change'}, {'measure': 'Instron Biomedical Testing', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'The Instron device measures the mechanical properties of the tissue.'}, {'measure': 'Face-Q: Satisfaction with Facial Appearance', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': "scale that measures a patient's overall satisfaction with how their face looks. It assesses things like symmetry, harmony, proportion, and vitality.\n\nA scale that measures a patient's overall satisfaction with how their face looks. It assesses things like symmetry, harmony, proportion, and vitality.\n\nA score from 0 to 100, where a higher score indicates a better outcome or greater satisfaction"}, {'measure': 'Face-Q: Satisfaction with Outcome', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': 'A series of positively worded questions to ask patients directly how they feel about the outcome.\n\nA score from 0 to 100, where a higher score indicates greater satisfaction with the outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tissue Adhesion']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria\n\nInclusion Criteria\n\n1. Healthy adults 18-80 years of age\n2. Planned/scheduled rhytidectomy at UT Southwestern with the study doctor\n3. Willing to return for follow up visits and undergo study evaluations\n\nExclusion Criteria\n\n1. Individuals diagnosed with known reaction to device material (tetracycline hydrochloride, kanamycin sulfate, etc)\n2. Individuals who have significant scarring on the test area\n3. Individuals with a disorder to negatively affect wound healing'}, 'identificationModule': {'nctId': 'NCT07132892', 'briefTitle': 'Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Clinical Use of Poly-4-Hydroxybutyrate Scaffold in Rhytidectomy- A Pilot Study', 'orgStudyIdInfo': {'id': 'STU20251603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Participants', 'description': 'Healthy subjects who received an elective rhytidectomy\n\nThe 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.', 'interventionNames': ['Device: Galaflex Lite Scaffold']}], 'interventions': [{'name': 'Galaflex Lite Scaffold', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Healthy Participants']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jennifer Barillas', 'role': 'CONTACT', 'email': 'jennifer.barillas@utsouthwestern.edu', 'phone': '214-645-8907'}, {'name': 'Debby Noble', 'role': 'CONTACT', 'email': 'debby.noble@utsouthwestern.edu', 'phone': '214-648-8686'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeffrey M. Kenkel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman and Professor', 'investigatorFullName': 'Jeffrey M. Kenkel', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}