Local antibiotic beads to prevent infection after breast tissue expander placement
Official title: A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
Run by Memorial Sloan Kettering Cancer Center · NCT07220967 · Data updated 2026-11-12
This study will test whether placing biodegradable antibiotic beads at the time of immediate prepectoral tissue expander reconstruction lowers infection and seroma risk for adult women having mastectomy reconstruction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 392 (estimated) |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07220967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women planned for immediate prepectoral tissue expander reconstruction at MSK who are non-smokers, have BMI under 40, no allergy to calcium sulfate or the study antibiotics, and no listed medical contraindications.
✕Probably not a fit
Patients with contraindications such as pregnancy, uncontrolled diabetes, severe vascular or neurological disease, active smoking, BMI ≥40, or known allergy to calcium sulfate, vancomycin, or gentamicin are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial uses vancomycin- and gentamicin-loaded Stimulan Rapid Cure (calcium sulfate) beads placed at the surgical site during prepectoral tissue expander insertion. Participants are adult women undergoing immediate reconstruction at Memorial Sloan Kettering's New Jersey sites who meet specified health and allergy criteria. Investigators will follow patients after surgery to track surgical-site infections, seroma formation, device-related complications, and any adverse events. This phase 4 interventional protocol evaluates the real-world safety and outcome effects of local antibiotic delivery in this patient population.
Why it matters
Potential benefit: If successful, the approach could lower post-operative infection and seroma rates, reduce reoperations, and help preserve reconstructive outcomes.
How similar studies have gone: Antibiotic-loaded calcium sulfate beads have reduced infection rates in orthopedic and some implant surgeries, but their routine use with breast tissue expanders is relatively novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States Recruiting -
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States Recruiting -
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States Recruiting -
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States Recruiting -
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States Recruiting -
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States Recruiting
Show 1 more location
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Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States Recruiting
Study contacts
- Principal investigator: Danielle Rochlin, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Danielle Rochlin, MD
- Email: rochlind@mskcc.org
- Phone: 646-608-8033
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.