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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling

Phase 4

Conditions

Breast Cancer

Treatments

Device: Stimulan Rapid Cure

Procedure: Tissue Expander (TE)

Drug: Vancomycin and Gentamicin

Study type

Interventional

Funder types

Other

Identifiers

NCT07220967

25-278

Details and patient eligibility

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.

Enrollment

392 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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