Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
NCT07220967

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09

392

Participants Needed

7

Research Sites

101 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 with prepectoral tissue expander 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 including 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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

D

Danielle Rochlin, MD

CONTACT

B

Babak Mehrara, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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