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

Last updated: December 3, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

4

Condition

Breast Cancer

Cancer

Treatment

Tissue Expander (TE)

Stimulan Rapid Cure

Vancomycin and Gentamicin

Clinical Study ID

NCT07220967
25-278
  • Ages > 18
  • Female

Study Summary

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 Criteria

Inclusion

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

Study Design

Total Participants: 392
Treatment Group(s): 3
Primary Treatment: Tissue Expander (TE)
Phase: 4
Study Start date:
October 21, 2025
Estimated Completion Date:
October 31, 2027

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge 5095409, New Jersey 5101760 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale 5101361, New Jersey 5101760 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

    Commack 5113412, New York 5128638 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison 5120095, New York 5128638 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre 5134203, New York 5128638 11553
    United States

    Active - Recruiting

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