Back to Trials
NCT07220967PHASE4Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

10/21/2025

Completion Date

10/1/2027

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

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Tissue Expander (TE)

DRUG

Vancomycin and Gentamicin

DEVICE

Stimulan Rapid Cure

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Breast Cancer

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York 11553

United States