Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 10:05 AM
Study NCT ID:
NCT02688634
Status:
WITHDRAWN
Last Update Posted:
2017-12-21
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002972', 'term': 'Cleft Palate'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-19', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infection rates between the groups', 'timeFrame': '30 days', 'description': "Analysis of infection is based on a 7 point scale to allow for broadened data but can be evaluated in a binary fashion for ≥ 4 indicating infection and \\<4 as no infection. A χ2 test and Fisher's exact test for p\\<0.05 will be used to determine significance of the difference in complication (cellulitis and upper respiratory infection) rates between the two groups."}, {'measure': 'Dehiscence and fistula formation between the groups', 'timeFrame': '30 days', 'description': 'Both dehiscence and fistula formation will also be recorded as a binary present/not present data point to determine the significance of the difference in complication rates between the groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cleft Palate Surgery', 'Antibiotic treatment'], 'conditions': ['Cleft Palate']}, 'descriptionModule': {'briefSummary': 'Cleft Lip and Palate surgical repair is one of the most common procedures performed by Plastic and Reconstructive Surgeons in the World. With this in mind, it is curious that no consensus exists regarding the usage of postoperative antibiotics or the effects this might have on wound complications such as cellulitis, dehiscence, or fistula formation. The surgical bed in cleft lip/palate repair is known to harbor a myriad of pathological organisms, indeed the human bite is one of the more clinically and microbiologically significant injuries to treat. This research study is to elucidate the role, if any, that prophylactic antibiotics have in the prevention of complications post cleft palate (CP) and VPI repair and potentially establish a new paradigm of care.', 'detailedDescription': 'This will be a randomized prospective research study. Participants who will undergo an elective CP or VPI surgery will be randomized to receive either 1) antibiotics or 2) nothing postoperatively. All participants will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing independently scheduled elective Cleft Palate of VPI repair at an area hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 1 month to 60 years\n2. Subjects undergoing independently scheduled elective Cleft Palate of VPI repair\n3. Do not meet any exclusion criteria\n\nExclusion Criteria:\n\n1. Any repeat repair\n2. Symptoms of upper respiratory infection\n3. Immunosuppressed\n4. Allergy to Amoxicillin or any other Penicillins\n5. Antibiotic usage \\<2weeks prior to scheduled surgery other than immediate pre-operative antibiotics\n6. Inability to follow up'}, 'identificationModule': {'nctId': 'NCT02688634', 'acronym': 'Cleft Palate', 'briefTitle': 'The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'The Role of Antibiotic Prophylaxis in Cleft Palate and Velopharyngeal Insufficiency Repair', 'orgStudyIdInfo': {'id': 'IRB201500667'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'Participants in this group are randomize to receive post-operative antibiotic of Amoxicillin x7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.', 'interventionNames': ['Drug: Amoxicillin']}, {'label': 'Non-Treatment', 'description': 'Participants in this group will be randomize to no post-operative antibiotic. They will be evaluated for infection, fistula formation, and dehiscence upon discharge and at 30-day follow-up based on standards of care.'}], 'interventions': [{'name': 'Amoxicillin', 'type': 'DRUG', 'otherNames': ['Antibiotics'], 'description': 'Amoxicillin will be given as: 7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health at Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Ashley Lentz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}