A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
Memorial Sloan Kettering Cancer Center
392 participants
Oct 21, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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
Tissue Expander (TE)
Given through Stimulan Rapid Cure during surgery
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07220967