Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-24 @ 5:44 AM
Study NCT ID:
NCT02413658
Status:
UNKNOWN
Last Update Posted:
2015-04-10
First Post:
2015-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenytoin in the Healing of Clean Surgical Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010672', 'term': 'Phenytoin'}], 'ancestors': [{'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage rate of re-epithelialization', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 20 days', 'description': 'Pictures taken of wound site every other day will be analysed using imaging software for size of wound. Percentage rate will be calculated from this.'}, {'measure': 'Appearance of infection', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an expected average of 20 days', 'description': 'Pictures taken of wound site every other day will be analysed using imaging software and the Southampton wound grading scale'}]}, 'conditionsModule': {'keywords': ['Phenytoin', 'Skin graft donor site', 'Clean surgical site', 'Wound model'], 'conditions': ['Wound', 'Re-Epithelialization']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the potential healing properties of phenytoin.\n\nThe investigators will use the donor site of a split skin thickness graft (SSTG) to model a basic wound in a randomized controlled trial of topical phenytoin against current best clinical practice. The investigators aim to demonstrate a dose dependent effect. The investigators hypothesis, based on previous clinical experience at our center and on current available literature, that phenytoin will reduce wound healing time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Undergoing split thickness skin graft during trial time period at Children's Surgical Centre\n\nExclusion Criteria:"}, 'identificationModule': {'nctId': 'NCT02413658', 'briefTitle': 'Phenytoin in the Healing of Clean Surgical Wounds', 'organization': {'class': 'OTHER', 'fullName': "Children's Surgical Center, Cambodia"}, 'officialTitle': 'Phenytoin in the Healing of Clean Surgical Wounds', 'orgStudyIdInfo': {'id': '1CSC2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Dressings of best current clinical practice, sugar solution.', 'interventionNames': ['Drug: Sugar solution']}, {'type': 'EXPERIMENTAL', 'label': 'Phenytoin 1', 'description': 'Dressings using phenytoin solution 20mg/ml', 'interventionNames': ['Drug: Phenytoin']}, {'type': 'EXPERIMENTAL', 'label': 'Phenytoin 2', 'description': 'Dressings using phenytoin solution 40mg/ml', 'interventionNames': ['Drug: Phenytoin']}], 'interventions': [{'name': 'Phenytoin', 'type': 'DRUG', 'otherNames': ['Dilantin, Dilantin-125'], 'description': 'Topical use of phenytoin solution on dressings of split thickness skin graft sites.', 'armGroupLabels': ['Phenytoin 1', 'Phenytoin 2']}, {'name': 'Sugar solution', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phnom Penh', 'status': 'RECRUITING', 'country': 'Cambodia', 'contacts': [{'name': 'Jim Gollogly', 'role': 'CONTACT', 'email': 'jim@csc.org', 'phone': '+85512979124'}], 'facility': "Children's Surgical Centre", 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}], 'centralContacts': [{'name': 'Jim Gollogly', 'role': 'CONTACT', 'email': 'jim@csc.org', 'phone': '+85512979214'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Surgical Center, Cambodia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}