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Preventing Infection After Breast Tissue Expander Placement

This study is looking at whether using Vancomycin and Gentamicin delivered through a device called Stimulan Rapid Cure during surgery can help prevent infections after breast tissue expanders are placed. Tissue expanders are used during breast reconstruction after a mastectomy (surgery to remove breast tissue). Researchers also want to see if Stimulan Rapid Cure affects the risk of seroma, which is a fluid buildup under the skin. You may be able to join if you are a woman aged 18 or older who is having a mastectomy and immediate breast reconstruction. The study will be considered successful if fewer surgical site infections occur within 90 days after surgery in patients who receive the antibiotics compared to those who don't. The current status of this study is unclear.

Study design
This interventional study plans to enroll 392 women. It compares patients who receive antibiotics through Stimulan Rapid Cure to those who only receive a tissue expander.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for surgical site infections within 90 days after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220967

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~392 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Tissue Expander (TE)Vancomycin and GentamicinStimulan Rapid Cure

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
Measured over within 90 days postoperatively
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast CarcinomaMammoplasty

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Danielle Rochlin, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Danielle Rochlin, MD
[email protected]
646-608-8033
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

What this trial measures

  • Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)within 90 days postoperatively

    The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively

  • Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only)within 90 days postoperatively

    The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively