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Local Antibiotic Delivery using the Stimulan Rapid Cure Device for the Prevention of Infection after Breast Reconstruction with Tissue Expanders
Trial Status: active
This phase IV trial studies how well local antibody delivery using the Stimulan Rapid Cure device works in preventing infections after breast reconstruction surgery with tissue expanders (TEs) among women with breast cancer or who have genes that increase the risk of breast cancer. Usual care includes antibiotics given as an intravenous infusion into a vein in the arm at the time of surgery and by mouth after surgery. Stimulan Rapid Cure is a medical device made from a type of calcium that is safely absorbed by the body. During surgery, it is mixed with antibiotics such as vancomycin and gentamicin to form a paste. The paste is formed into small beads, and the beads are placed in areas at risk of infection. Once inside the body, they slowly dissolve over several weeks, releasing antibiotics directly to the area where they are needed most. Because they dissolve on their own, no second surgery is required to remove them. This may help reduce the chance of infection and support healing. Stimulan Rapid Cure may help decrease risk of infection after tissue expander placement.
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 Memorial Sloan Kettering (MSK)
Body mass index (BMI) less than 40 kg/m^2
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
Additional locations may be listed on ClinicalTrials.gov for NCT07220967.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Danielle Rochlin
Phone: 646-608-8033
PRIMARY OBJECTIVE:
I. Estimate and compare the incidence of surgical site infection (SSI) in women undergoing breast reconstruction with TEs with and without the use of antibiotic beads.
SECONDARY OBJECTIVE:
I. Estimate and compare the rates of seroma in women undergoing breast reconstruction with TEs with and without the use of antibiotic beads.
EXPLORATORY OBJECTIVE:
I. Measure the cost-effectiveness of antibiotic bead use in TE-based breast reconstruction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive vancomycin and gentamicin via Stimulan Rapid Cure antibiotic beads during standard of care (SOC) breast reconstruction with TEs on study.
ARM II: Patients undergo SOC breast reconstruction with TEs on study.
After completion of study treatment, patients are followed for 90 days.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
