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
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