A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
NCT07220967 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 392
Last updated 2026-04-09
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.
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
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Danielle Rochlin, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-21
- Primary Completion
- 2027-10-31
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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