Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT07075159
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with wound dehiscence', 'timeFrame': '3 months', 'description': 'YES/NO type question if wound dehiscence is present after removal of the patch'}], 'secondaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale', 'timeFrame': '3 months', 'description': 'Patient and Observer Scar Assessment Scale filled out by both patient and provider at postoperative visit of both HCD Dressing and ointment. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound Healing', 'Mohs Micrographic Surgery', 'Oculofacial Reconstruction']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the use of a hydrocolloid dressing (DuoDERM EXTRA THIN) as an alternative to the current standard of care. The dressing would be applied immediately after surgery and removed at a post-operative week 1 appointment. The dressing would eliminate the need for antibiotic ointment application and reduce the burden of post-operative care on the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years of age\n* follow-up at specified intervals (1 week/6 week/3 months) in an office setting\n* can give informed consent\n* no patients will be excluded on the basis of gender, ethnicity, or religious background\n\nExclusion Criteria:\n\n* Patients \\<18 years of age or \\>100\n* allergy to pectin, gelatin, and sodium carboxymethylcellulose\n* adults with impaired consent capacity\n* incarcerated individuals.'}, 'identificationModule': {'nctId': 'NCT07075159', 'acronym': 'HCD Wound Heal', 'briefTitle': 'Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Hydrocolloid Dressings for Oculofacial Plastic and Reconstructive Wound Healing', 'orgStudyIdInfo': {'id': '99942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wound Dressing', 'description': 'At the conclusion of the surgical procedure, patients will receive topical wound dressing to surgical sutured periocular wounds', 'interventionNames': ['Device: Hydrocolloid Wound Dressing']}, {'type': 'NO_INTERVENTION', 'label': 'Antibiotic Ointment (Control)', 'description': 'At the conclusion of the surgical procedure, patients will receive topical antibiotic ophthalmic ointment to surgical sutured periocular wounds'}], 'interventions': [{'name': 'Hydrocolloid Wound Dressing', 'type': 'DEVICE', 'otherNames': ['DuoDERM Extra Thin dressing'], 'description': 'one time hydrocolloid dressing application', 'armGroupLabels': ['Wound Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40508', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janice Hernandez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Connie Dampier', 'role': 'CONTACT', 'email': 'dampier@uky.edu', 'phone': '859-562-0750'}], 'overallOfficials': [{'name': 'Janice Hernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janice Hernandez, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Janice Hernandez, MD', 'investigatorAffiliation': 'University of Kentucky'}}}}