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

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Tissue Expander (TE); Drug: Vancomycin and Gentamicin; Device: Stimulan Rapid Cure

• Registration Number: NCT07220967
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-21
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-24
• Last Update Submitted: 2025-10-24
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Primary Completion: 2027-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 392

Inclusion Criteria

• Female sex
• Aged 18 to 75 years
• Diagnosis of breast cancer or genetic predisposition to breast cancer
• Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK
• English speaking
• BMI less than 40 kg/m2
• Not actively smoking or using other nicotine products within 6 weeks of surgery
• Not actively using steroids and/or immunosuppressant medication
• No history of radiation to the breast (either neoadjuvant or for prior treatment)
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients randomized to Tissue Expander (TE) + antibiotic beads	Tissue Expander (TE)	-
Patients randomized to Tissue Expander (TE) + antibiotic beads	Vancomycin and Gentamicin	-
Patients randomized to Tissue Expander (TE) + antibiotic beads	Stimulan Rapid Cure	-
Patients randomized to Tissue Expander (TE) only	Tissue Expander (TE)	-

Primary Outcome Measures

Name	Time	Method
Surgical site infections (SSI) incidence	within 90 days postoperatively	We will define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively

Secondary Outcome Measures

Name	Time	Method
Compare the rates of seroma	within 90 days postoperatively	Seroma is defined as \>50 cc of periprosthetic fluid that is aspirated during tissue expansions or otherwise drained (e.g., by Interventional Radiology). Seroma will be assessed at the patient level such that unilateral or bilateral seroma in a patient will be considered a single seroma event for the purposes of analysis.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States