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A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement

RecruitingPhase 4Ages 18 Years - anyFemaleMemorial Sloan Kettering Cancer Center
NCT07220967 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female sex * 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
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What it tests

  • Tissue Expander (TE)
  • Vancomycin and Gentamicin
  • Stimulan Rapid Cure
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Where

7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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