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

Recruiting now · Phase 4

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07220967

Run by

Memorial Sloan Kettering Cancer Center

People needed

392

Starts

2025-10-21

Expected to finish

2027-10-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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