A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tissue Expander (TE), Vancomycin and Gentamicin, Stimulan Rapid Cure.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
Overview
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.
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
Primary outcome measures
- Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads) [Time frame: within 90 days postoperatively]
- Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only) [Time frame: within 90 days postoperatively]
Secondary outcome measures (2)
- Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads) [Time frame: within 90 days postoperatively]
- Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only) [Time frame: within 90 days postoperatively]
Eligibility criteria
Inclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre
Identifiers
NCT: NCT07220967 · 25-278