Dysautonomia International

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		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
Active Comparator Patients randomized to Tissue Expander (TE) only		Procedure: Tissue Expander (TE) Tissue Expander (TE)

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge 5095409, New Jersey 5101760 07920

Contact:
Danielle Rochlin, MD
646-608-8033
rochlind@mskcc.org

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown 5101170, New Jersey 5101760 07748