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

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

Recruiting
18-75 years
Female
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  • Female sex
  • Aged 18 to 75 years
  • Diagnosis of breast cancer or genetic predisposition to breast cancer
  • Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK
  • English speaking
  • BMI less than 40 kg/m2
  • Not actively smoking or using other nicotine products within 6 weeks of surgery
  • Not actively using steroids and/or immunosuppressant medication
  • No history of radiation to the breast (either neoadjuvant or for prior treatment)
  • 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

Study details
    Breast Cancer

NCT07220967

Memorial Sloan Kettering Cancer Center

31 October 2025

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