Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04321967
Status:
WITHDRAWN
Last Update Posted:
2022-11-08
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nitropaste in Breast Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006177', 'term': 'Gynecomastia'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D009336', 'term': 'Necrosis'}], 'ancestors': [{'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100832', 'term': 'octyl 2-cyanoacrylate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The patient will be masked and will not know which breast received the nitropaste. The investigator who applied nitropaste will know which breast was treated, but the investigator who conducts the follow-up visits will not.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who agree to participate will be randomized during their bilateral breast reduction procedure. Each patient will be randomized to "LEFT BREAST" or "RIGHT BREAST." The randomization result will determine which breast receives the nitroglycerin paste. Their breast reduction will be done using the Wise pattern, and all incisions will be sealed with Dermabond. At the conclusion of the procedure, 1g of topical nitroglycerin (2%) will be placed on the breast which the randomizer indicated. Patients will be monitored for AEs during the remainder of their hospital stay.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vancouver Scar Scoring (VSS)', 'timeFrame': 'First post-op visit (0 weeks post op) and last visit at 12 months', 'description': 'Change in Vancouver Scar Scoring at 12 as compared to first post visit. VSS is a standardized scar appearance protocol - full score from 0-13, with higher score indicating poorer health outcomes.'}], 'secondaryOutcomes': [{'measure': 'Number of occurrences of wound breakdown', 'timeFrame': '12 months', 'description': 'Change in number of occurrence of necrosis and/or wound breakdown at 12 months as compared to the first post-op visit'}, {'measure': 'Number of side-effects of Nitroglycerin use', 'timeFrame': '12 months', 'description': 'Side effects of nitroglycerine use measured as a composite of side effects which includes pre-syncope, syncope, chest pains and headache.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nitroglycerin paste', 'Scarring', 'Necrosis', 'Wound healing', 'Breast', 'Breast reduction'], 'conditions': ['Gynecomastia', 'Delayed Wound Healing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.', 'detailedDescription': 'This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are female and transmen\n* Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic\n* Reduction must be performed via Wise incisional pattern\n\nExclusion Criteria:\n\n* Patients who are male or transwomen\n* Patients who are under 18 years of age'}, 'identificationModule': {'nctId': 'NCT04321967', 'briefTitle': 'Nitropaste in Breast Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction', 'orgStudyIdInfo': {'id': 'GCO 19-0387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitroglycerine paste', 'description': 'The randomized breast will receive Nitroglycerine paste and Dermabond.', 'interventionNames': ['Drug: Nitroglycerin Paste', 'Drug: Dermabond']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dermabond', 'description': 'The control breast will receive Dermabond only', 'interventionNames': ['Drug: Dermabond']}], 'interventions': [{'name': 'Nitroglycerin Paste', 'type': 'DRUG', 'description': '1g of 2% Nitroglycerin paste topical application', 'armGroupLabels': ['Nitroglycerine paste']}, {'name': 'Dermabond', 'type': 'DRUG', 'description': 'Topical skin adhesive', 'armGroupLabels': ['Dermabond', 'Nitroglycerine paste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter Taub, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD and related data dictionaries available. The PI does not plan to share data at the conclusion of the study beyond what is published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter J. Taub', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}