Study of Local Antibiotic Delivery Using Stimulan Rapid Cure to Prevent Infections After Breast Tissue Expander Placement During Mastectomy

What this Trial Is About

Researchers are evaluating whether Stimulan Rapid Cure can reduce infections in people undergoing tissue expander placement during mastectomy for breast cancer or related preventive reasons. The study also examines if this antibiotic delivery affects the risk of seroma, a complication involving fluid buildup after surgery. This is a randomized, phase 4 clinical trial assessing the prevention of breast tissue expander-associated infections. Participants are assigned to one of two groups one receives tissue expanders with antibiotic beads containing vancomycin and gentamicin delivered through Stimulan Rapid Cure during surgery, and the other receives tissue expanders alone. The study compares infection and seroma rates within 90 days after surgery to evaluate the effectiveness of the antibiotic delivery device. During the trial, participants will undergo mastectomy with immediate breast reconstruction using prepectoral tissue expanders at Memorial Sloan Kettering Cancer Center. Researchers will monitor surgical site infections and seroma formation for 90 days postoperatively. The study involves regular follow-up to assess these outcomes and ensure participant safety throughout the trial period.

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