A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Device, Procedure
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
RECRUITING
Rockville Centre
Contact Information
Primary
Danielle Rochlin, MD
rochlind@mskcc.org
646-608-8033
Backup
Babak Mehrara, MD
646-608-8639
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2027-10
Participants
Target number of participants: 392
Treatments
Experimental: Patients randomized to Tissue Expander (TE) + antibiotic beads
Active_comparator: Patients randomized to Tissue Expander (TE) only
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov