A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
NCT ID: NCT07220967
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
392 participants
INTERVENTIONAL
2025-10-21
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients randomized to Tissue Expander (TE) + antibiotic beads
Tissue Expander (TE)
Tissue Expander (TE)
Vancomycin and Gentamicin
Given through Stimulan Rapid Cure during surgery
Stimulan Rapid Cure
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
Patients randomized to Tissue Expander (TE) only
Tissue Expander (TE)
Tissue Expander (TE)
Interventions
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Tissue Expander (TE)
Tissue Expander (TE)
Vancomycin and Gentamicin
Given through Stimulan Rapid Cure during surgery
Stimulan Rapid Cure
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or older
* Planned to undergo mastectomy for breast cancer, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication
* Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK
* BMI less than 40 kg/m2
* Not actively smoking or using other nicotine products within 6 weeks of surgery
* No contraindications to Stimulan antibiotic bead placement: hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, and severe degenerative bone disease
* No known allergy to calcium sulfate, vancomycin, or gentamicin
* No impaired decision-making capacity
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Danielle Rochlin, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States
Countries
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Central Contacts
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Babak Mehrara, MD
Role: CONTACT
Facility Contacts
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Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Danielle Rochlin, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-278
Identifier Type: -
Identifier Source: org_study_id
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