A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a randomized controlled study to compare the outcomes of immediate tissue expander (TE)-based breast reconstruction with and without antibiotic beads.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients randomized to Tissue Expander (TE) + antibiotic beads |
|
|
|
Active Comparator Patients randomized to Tissue Expander (TE) only |
|
Recruiting Locations
Basking Ridge, New Jersey 07920
Middletown, New Jersey 07748
Danielle Rochlin, MD
646-608-8033
Montvale, New Jersey 07645
Danielle Rochlin, MD
646-608-8033
Commack, New York 11725
Danielle Rochlin, MD
646-608-8033
Harrison, New York 10604
Danielle Rochlin, MD
646-608-8033
New York, New York 10065
Danielle Rochlin, MD
646-608-8033
Rockville Centre, New York 11553
Danielle Rochlin, MD
646-608-8033
More Details
- Status
- Recruiting
- Sponsor
- Memorial Sloan Kettering Cancer Center