Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT07220967
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015625', 'term': 'Tissue Expansion Devices'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled study to compare the outcomes of immediate tissue expander (TE)-based breast reconstruction with and without antibiotic beads.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 392}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-10-22', 'studyFirstSubmitQcDate': '2025-10-24', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infections (SSI) incidence', 'timeFrame': 'within 90 days postoperatively', 'description': 'We will define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \\[seroma, radiation\\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively'}], 'secondaryOutcomes': [{'measure': 'Compare the rates of seroma', 'timeFrame': 'within 90 days postoperatively', 'description': 'Seroma is defined as \\>50 cc of periprosthetic fluid that is aspirated during tissue expansions or otherwise drained (e.g., by Interventional Radiology). Seroma will be assessed at the patient level such that unilateral or bilateral seroma in a patient will be considered a single seroma event for the purposes of analysis.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Tissue Expander Placement', 'Stimulan Rapid Cure', 'Local Antibiotic Delivery', 'Prevent Infection', '25-278'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue expanders placed during mastectomy. The researchers will also study whether Stimulan Rapid Cure affects the risk of seroma, a possible complication of surgery that involves fluid buildup under the skin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Breast Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female sex\n* Aged 18 years or older\n* Planned to undergo mastectomy for breast cancer, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication\n* Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK\n* BMI less than 40 kg/m2\n* Not actively smoking or using other nicotine products within 6 weeks of surgery\n* No contraindications to Stimulan antibiotic bead placement: hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, and severe degenerative bone disease\n* No known allergy to calcium sulfate, vancomycin, or gentamicin\n* No impaired decision-making capacity'}, 'identificationModule': {'nctId': 'NCT07220967', 'briefTitle': 'A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections', 'orgStudyIdInfo': {'id': '25-278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients randomized to Tissue Expander (TE) + antibiotic beads', 'interventionNames': ['Procedure: Tissue Expander (TE)', 'Drug: Vancomycin and Gentamicin', 'Device: Stimulan Rapid Cure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients randomized to Tissue Expander (TE) only', 'interventionNames': ['Procedure: Tissue Expander (TE)']}], 'interventions': [{'name': 'Tissue Expander (TE)', 'type': 'PROCEDURE', 'description': 'Tissue Expander (TE)', 'armGroupLabels': ['Patients randomized to Tissue Expander (TE) + antibiotic beads', 'Patients randomized to Tissue Expander (TE) only']}, {'name': 'Vancomycin and Gentamicin', 'type': 'DRUG', 'description': 'Given through Stimulan Rapid Cure during surgery', 'armGroupLabels': ['Patients randomized to Tissue Expander (TE) + antibiotic beads']}, {'name': 'Stimulan Rapid Cure', 'type': 'DEVICE', 'description': 'Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery', 'armGroupLabels': ['Patients randomized to Tissue Expander (TE) + antibiotic beads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'email': 'rochlind@mskcc.org', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Rockville Centre', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'phone': '646-608-8033'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activites)', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}], 'centralContacts': [{'name': 'Danielle Rochlin, MD', 'role': 'CONTACT', 'email': 'rochlind@mskcc.org', 'phone': '646-608-8033'}, {'name': 'Babak Mehrara, MD', 'role': 'CONTACT', 'phone': '646-608-8639'}], 'overallOfficials': [{'name': 'Danielle Rochlin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}