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RECRUITING
NCT07220967
PHASE4

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

392

Start Date

2025-10-21

Completion Date

2027-10

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Tissue Expander (TE)

Tissue Expander (TE)

DRUG

Vancomycin and Gentamicin

Given through Stimulan Rapid Cure during surgery

DEVICE

Stimulan 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