Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-11 @ 8:35 PM
Study NCT ID:
NCT06428669
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Nitropaste in Chest Masculinizing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068116', 'term': 'Gender Dysphoria'}], 'ancestors': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}, {'id': 'D009824', 'term': 'Ointments'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-20', 'size': 832469, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-24T15:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-05-20', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free Nipple Graft Take', 'timeFrame': 'Will be assessed at 5 days, 2 weeks, 6 weeks post-op', 'description': 'Rate of partial nipple graft loss (0-50%, 50% or more) or Complete nipple graft loss'}, {'measure': 'Wounds', 'timeFrame': 'Will be assessed at 5 days, 2 weeks, 6 weeks post-op', 'description': 'Rate of superficial wound, deep wound, delayed wound healing'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Will be tracked up until 3 months post-op', 'description': 'hematoma, seroma, infection, hypertrophic scarring'}, {'measure': 'Sharp debridement', 'timeFrame': 'Will be tracked up until 3 months post-op', 'description': 'Need for any sharp debridement (office or OR)'}, {'measure': 'Revision', 'timeFrame': 'Will be tracked up until 3 months post-op', 'description': 'Need for any revision'}, {'measure': 'Readmission', 'timeFrame': 'Will be tracked 30 days', 'description': '30 day ED or inpatient admission rate'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gender affirming surgery', 'Chest masculinizing Surgery', 'Nitropaste', 'Wound healing'], 'conditions': ['Gender Dysphoria']}, 'descriptionModule': {'briefSummary': "Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery.", 'detailedDescription': "Nitropaste is a topical agent that contains 2% nitroglycerin. It is an effective vascular smooth dilator, with more powerful effect on venous vasculature than arterial vasculature. While its main indication is for angina pectoris, there have been many studies showing improved survival of axial and random pattern flaps. Furthermore, recent clinical studies highlight significantly decreased mastectomy flap wound complication and need for sharp debridement. Nitropaste has low rates of side effects and is very well tolerated in general. To this date, there's no study that investigates its utility on patients who are undergoing chest masculinizing surgery. The purpose of this study is to investigate the potential utility of nitropaste in reducing rates of wound complications in patients undergoing chest masculinizing surgery utilizing double incision with free nipple grafting technique. The investigators will conduct a prospective, randomized, single-blinded study and compare nitropaste vs. no nitropaste on mastectomy flaps. Nitropaste will be applied intraoperatively and the patients will not have to re-apply it. Follow up will occur on post-op day 5, 2 weeks, and 6 weeks during their routine postop visits. A study coordinator will document the condition of free nipple grafts and any other wounds at surgical site if present, which will be the primary outcome. Any complications including hematoma, seroma, infection, hypertrophic scarring, need for sharp debridement, 30 day ED visit or admission rates will be documented as secondary outcome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any adult (18 or older) patients of any gender identity who are undergoing chest masculinizing surgery with double incision and free nipple grafting.\n\nExclusion Criteria:\n\n* Minor patients (younger than 18)\n* Anyone who's not getting free nipple grafting\n* Anyone who's not utilizing double incision pattern\n* Prisoners, anyone who is allergic to nitropaste\n* Anyone who is taking phosphodiesterase inhibitor (ex)Sildenafil, tadalafil, vardenafil)\n* Anyone who's taking soluble guanylate cyclase stimulator riociguatdz"}, 'identificationModule': {'nctId': 'NCT06428669', 'briefTitle': 'Effect of Nitropaste in Chest Masculinizing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'The Effect of Nitropaste in Chest Masculinizing Surgery: Randomized, Prospective Trial', 'orgStudyIdInfo': {'id': 'HSR220217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No nitropaste group', 'description': 'Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.'}, {'type': 'EXPERIMENTAL', 'label': 'Nitropaste group', 'description': 'Participants get standard of care chest masculinizing surgery utilizing double incision and free nipple grafting surgery. They will then get 2 packets of nitropaste applied (1 on each chest) around the free nipple graft and surgical sites. They will then get standard dressing applied, which includes Xeroform bolster over the nipple grafts + Tegederm over the bolster and surgical site and instructed not to remove the dressing until they come to clinic on POD5 for bolster take down.', 'interventionNames': ['Drug: Nitro-Bid 2 % Topical Ointment']}], 'interventions': [{'name': 'Nitro-Bid 2 % Topical Ointment', 'type': 'DRUG', 'description': 'Intervention group will get 30mg of Nitro-Bid topical ointment applied over the chest (15mg/ 1 packet on each side) one time intra-operatively', 'armGroupLabels': ['Nitropaste group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel H Park, MD', 'role': 'CONTACT', 'email': 'rhp7gu@hscmail.mcc.virginia.edu', 'phone': '571-428-7278'}], 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Rachel H Park, MD', 'role': 'CONTACT', 'email': 'rhp7gu@hscmail.mcc.virginia.edu', 'phone': '434-327-2140'}], 'overallOfficials': [{'name': 'John T Stranix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UVA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Plastic Surgery', 'investigatorFullName': 'John Stranix', 'investigatorAffiliation': 'University of Virginia'}}}}