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

RECRUITINGPhase 4Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 4
SponsorMemorial Sloan Kettering Cancer Center
Started2025-10-21
Est. completion2027-10
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations7 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

Locations7 sites

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Danielle Rochlin, MD646-608-8033rochlind@mskcc.org
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Danielle Rochlin, MD646-608-8033
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Danielle Rochlin, MD646-608-8033
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Danielle Rochlin, MD646-608-8033
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Danielle Rochlin, MD646-608-8033

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