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

StatusRecruiting
PhasePhase 4
Started2025-10-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-07-08
Study Status, Outcome Measures v4
Re-verified, no change to tracked fields
2026-07-07
Study Status, Outcome Measures v3
Primary endpoint(s) modified1 to 2 entries
WasSurgical site infections (SSI) incidence
NowSurgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only), Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
Secondary endpoints1 to 2 entries
Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads) Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only)
2026-04-03
Study Status v2
Re-verified, no change to tracked fields
2025-12-03
Study Status, Eligibility v1
Eligibility criteria-75 characters
Inclusion Criteria: Female sex Aged 18 years or older Planned to 75undergo years Diagnosismastectomy offor breast cancer or, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication Planned to undergo unilateral or bilateral immediate breast [...] he time of mastectomy) with prepectoral TE placement at MSK English speaking BMI less than 40 kg/m2 Not actively smoking or using other nicotine products within 6 weeks of surgery Not actively using steroids and/or immunosuppressant medication No history of radiation to the breast (either neoadjuvant or for p [...] [...]
2025-10-24
Original filing
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.
Trial Details
NCT Number NCT07220967
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Breast Cancer
Enrollment 392 participants
Start Date 2025-10-21
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-10