RecruitingPhase 4NCT07220967

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

A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

392 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing antibiotic-releasing beads inside the breast during reconstructive surgery (after mastectomy) can reduce the risk of post-surgery infections, which are a common and serious complication. **You may be eligible if...** - You are a woman, 18 or older, scheduled for mastectomy with immediate breast reconstruction using a tissue expander - Mastectomy is planned for breast cancer treatment, prevention, or due to high genetic risk - Your BMI is under 40 - You have not smoked or used nicotine products for at least 6 weeks before surgery - You have no known allergy to calcium sulfate, vancomycin, or gentamicin (antibiotic ingredients in the beads) **You may NOT be eligible if...** - You have high blood calcium, severe vascular or nerve disease, uncontrolled diabetes, or severe bone disease - You are pregnant - You have impaired decision-making ability Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETissue Expander (TE)

Tissue Expander (TE)

DRUGVancomycin and Gentamicin

Given through Stimulan Rapid Cure during surgery

DEVICEStimulan Rapid Cure

Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07220967


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