Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT07115212
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bromelain for Post-surgery Facial Swelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001963', 'term': 'Bromelains'}], 'ancestors': [{'id': 'D003546', 'term': 'Cysteine Endopeptidases'}, {'id': 'D057056', 'term': 'Cysteine Proteases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010450', 'term': 'Endopeptidases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Volume of Swelling', 'timeFrame': 'Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6', 'description': 'Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that undergo orthognathic surgery and measured in Cubic Centimeters. Will also have a heat map to visually show where swelling has increased or decreased since previously obtained imaging. All these images and measurements will be compared between the control and experimental groups.'}, {'measure': 'Duration of Swelling following Orthognathic Surgery', 'timeFrame': 'Baseline, and post intervention weeks 1, 2, 4, and months 3 and 6', 'description': 'Images will be obtained with the Vectra 3D imaging system to look at the volume of swelling in patients that underwent orthognathic surgery at multiple time periods. With comparisons of these multiple photos the duration of swelling can be assessed and compared to the average amount of time it takes swelling to go down in a patient not taking bromelain supplement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bromelain', 'Oral Supplements'], 'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Bromelain Supplement works to decrease the amount of swelling or the amount of time swelling is present following jaw surgery. It will also learn about the safety of Bromelain supplement. The main questions it aims to answer are:\n\nDoes Bromelain decrease facial swelling following orthognathic, or jaw, surgery? Does Bromelain supplement decrease the amount of time that patients are swollen following orthognathic, or jaw, surgery?\n\nParticipants will:\n\nTake Bromelain supplement once daily for 9 days total. Take 2 days before surgery and 7 days following surgery.\n\nKeep a log of when the bromelain supplement is taken as well as another other medications.\n\nVisit the clinic with pre and post surgical protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing orthognathic surgery\n\nExclusion Criteria:\n\n* craniofacial anomalies\n* incomplete patient data\n* systemic disease that could affect healing\n* allergy to latex or pineapple\n* under 18 years of age\n* non english speaking'}, 'identificationModule': {'nctId': 'NCT07115212', 'briefTitle': 'Bromelain for Post-surgery Facial Swelling', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Effectiveness of Bromelain Supplement in Reduction of Facial Swelling Caused by Orthognathic Surgery', 'orgStudyIdInfo': {'id': '99500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bromelain Supplement', 'description': '1000mg bromelain supplement once a day, 2 days prior to and 7 days following surgery', 'interventionNames': ['Dietary Supplement: Bromelain']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care'}], 'interventions': [{'name': 'Bromelain', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Naturebell'], 'description': '1 tablet daily with water, for 9 days-starting 2 days before surgery and continuing for 7 days after. Record each dose in the provided log, along with any other medications taken and the time they were taken.', 'armGroupLabels': ['Bromelain Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40356', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Emma E Palmer, DMD', 'role': 'CONTACT', 'email': 'emma.palmer@uky.edu', 'phone': '859-358-6346'}], 'overallOfficials': [{'name': 'Mohamed Bazina, DDS, MSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Bazina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Mohamed Bazina', 'investigatorAffiliation': 'University of Kentucky'}}}}