Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT05484934
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-10-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-08-01', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operative time in minutes', 'timeFrame': '12 months', 'description': 'One hour'}, {'measure': 'Physician Preference and Impressions', 'timeFrame': '12 months', 'description': 'Using a standardized survey (0-10 VAS Scale)'}, {'measure': 'Nipple sensitivity up to 12 months', 'timeFrame': '12 months', 'description': 'Using Semmes Weinstein Monofilament'}], 'primaryOutcomes': [{'measure': 'Time to complete healing (graft >99% re-epithelialized)', 'timeFrame': '3 months', 'description': 'To evaluate the time to complete healing following NAC reconstruction with DCLNAC.'}, {'measure': 'Healing of the nipple (VAS=Visual Analog Scale) epithelialization', 'timeFrame': '3 months', 'description': 'epithelialization (0-100% VAS)'}, {'measure': 'Healing of the nipple (VAS=Visual Analog Scale) granulation', 'timeFrame': '3 months', 'description': 'granulation (0-100% VAS)'}, {'measure': 'Healing of the nipple (VAS=Visual Analog Scale) ischemia/necrosis', 'timeFrame': '3 months', 'description': 'ischemia/necrosis (0-100% VAS)'}, {'measure': 'Healing of the nipple (VAS=Visual Analog Scale) dehiscence', 'timeFrame': '3 months', 'description': 'dehiscence (0-100% VAS)'}, {'measure': 'Healing of the nipple (VAS=Visual Analog Scale) overall healing', 'timeFrame': '3 months', 'description': 'overall healing (0-100% VAS)'}, {'measure': 'Healing of the nipple (infection) A. no infection B. hyperemia (no infection) C. cellulitis (superficial infection D. abscess or purulent infection', 'timeFrame': '3 months', 'description': 'As above'}], 'secondaryOutcomes': [{'measure': 'Nipple projection', 'timeFrame': '12 months', 'description': 'Distance from breast mound to tip in millimeters using depth gauge.'}, {'measure': 'Vascularization by presence of bleeding', 'timeFrame': '12 months', 'description': 'vascularization by presence of bleeding using a lancet device'}, {'measure': 'Evaluate patient satisfaction and well-being preoperatively and serially', 'timeFrame': '12 months', 'description': 'Use of a standardized postoperative survey with a LIKERT (numerical) scale up to 12 months following reconstruction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-Mastectomy Breast Deformity (Disorder)']}, 'descriptionModule': {'briefSummary': 'To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)', 'detailedDescription': 'Primary Objective\n\n• To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC).\n\nSecondary Objectives\n\n* To evaluate nipple dimensions and vascularization up to 12 months following nipple reconstruction using DCLNAC.\n* To evaluate patient satisfaction and well-being up to 12 months following nipple reconstruction using DCLNAC.\n\nExploratory Objectives\n\n* To assess operative time and physician preference for either the DCLNAC or the standard of care (SOC) surgical NAC reconstruction procedures.\n* To evaluate nipple sensitivity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* General Criteria:\n\n * Females age \\>18 and \\<65 years old. Women of childbearing potential must agree to use an acceptable method of contraception for one month prior to DCLNAC implantation, and until the graft is 100% healed. Acceptable forms of birth control include abstinence, birth control pills, or any double combination of: intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Nonchildbearing potential for women is defined as postmenopausal (last natural menses greater than 12 months) or undergone a documented bilateral tubal ligation or hysterectomy. If last natural menses less than 12 months, a serum FSH value confirming post-menopausal status can be employed.\n * Patient agrees to sleep on back until study tissue products are healed\n * Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until study tissue products are healed\n * Patient agrees to not undergo NAC tattooing until completing study\n * Patient can understand and willing to sign informed consent\n * Patient desires bilateral nipple reconstruction with DCLNAC\n * Subjects must be capable of providing written informed consent to the study procedures and for use of protected health information \\[Health Insurance Portability and Accountability Act (HIPAA), if applicable\\]\n\n * Specific Criteria\n\nGroup A:\n\n* Patient had a bilateral mastectomy with no radiation therapy\n* Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study\n\nGroup B:\n\n* Patient had a unilateral mastectomy with no radiation therapy\n* Patient has undergone a unilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study\n\nGroup C:\n\n* Patient had a bilateral mastectomy and received radiation unilaterally\n* Patient has undergone a bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study\n\nGroup D:\n\n\\- Patient had unilateral or bilateral mastopexy (with or without augmentation) or reduction mammaplasty and suffered nipple complications (i.e., necrosis, projection loss)\n\nGroup E:\n\n* Patient had unilateral or bilateral mastectomy\n* Patient had unilateral or bilateral autologous breast reconstruction a minimum of 3 months prior to enrolling in the study\n* Patient did not receive radiation to the autologously reconstructed breast\n* Patient had unilateral or bilateral nipple reconstruction that failed (i.e., necrosis, projection loss)\n\nGroup F:\n\n\\- Implant based reconstruction\n\nExclusion Criteria:\n\n* Patient has a history of delayed wound healing\n* Patient has a history of Vitamin C deficiency\n* BMI\\<18.5 or \\>40 kg/m2\n* Patient has a history of allergic reaction to any decellularized biologic matrix product\n* Patient is currently smoking or using tobacco or nicotine products (i.e., patch, gum, vaping or nasal spray) or has used such products in the past 6 months\n* Patient is currently receiving bilateral breast radiation or completed less than 3 months prior to screening\n* Patient has any systemic disease that would impede wound healing, such as diabetes or connective tissue disorders\n* Patient is pregnant, breastfeeding or planning to become pregnant during the study period\n* Patient has any type of disease or disorder that in the investigator's opinion would make the patient unfit for the study, including active infection anywhere in the body.\n* Acute mastitis in either breast\n* History of an autoimmune disorder\n* Use of any medications currently or in the past 3 months that would impair wound healing, such as long-term use of systemic steroids (inhaled, limited topical, short-term oral use and intra-articular steroids are acceptable)"}, 'identificationModule': {'nctId': 'NCT05484934', 'briefTitle': 'Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioAesthetics'}, 'officialTitle': 'Open Label Case Reports Investigating Wound Healing, Aesthetic Outcomes, and Patient Satisfaction Following Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)', 'orgStudyIdInfo': {'id': 'BA002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implant of acellular NAC graft', 'description': 'The implantation of the NAC acellular graft for regenerative nipple areolar complex', 'interventionNames': ['Procedure: Regenerative post mastectomy surgery']}], 'interventions': [{'name': 'Regenerative post mastectomy surgery', 'type': 'PROCEDURE', 'otherNames': ['Implantation of the NAC graft'], 'description': 'Implantation of the Nipple-Areolar Complex (NAC) Reconstruction Using a Decellularized Donor NAC Graft (DCLNAC)', 'armGroupLabels': ['Implant of acellular NAC graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70130', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Sullivan, MD', 'role': 'CONTACT', 'email': 'scottsullivanmd@gmail.com', 'phone': '504-899-2800'}], 'facility': 'St. Charles Surgical Hospital', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Susan Van Vactor', 'role': 'CONTACT', 'email': 'svanvactor@medsurgpi.com', 'phone': '9196049708'}, {'name': 'Gerald L. Klein, MD', 'role': 'CONTACT', 'email': 'gklein@medsurgpi.com', 'phone': '919-930-9180'}], 'overallOfficials': [{'name': 'Roger Morgan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MedSurgPI, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioAesthetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}