Recruiting

Stimulan Rapid Cure

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07220967

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tissue Expander (TE)

Vancomycin and Gentamicin

Stimulan Rapid Cure

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT07220967

Start date

Oct 21, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

392 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients randomized to Tissue Expander (TE) + antibiotic beads

active comparator: Patients randomized to Tissue Expander (TE) only

Interventions

Tissue Expander (TE)

Tissue Expander (TE)

Vancomycin and Gentamicin

Given through Stimulan Rapid Cure during surgery

Stimulan Rapid Cure

Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery

Primary outcome measure

  • Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads) [ Time Frame: within 90 days postoperatively ]
  • Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only) [ Time Frame: within 90 days postoperatively ]

Central Contacts and Locations

Central contacts

Danielle Rochlin, MD

646-608-8033rochlind@mskcc.org

Babak Mehrara, MD

646-608-8639

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Danielle Rochlin, MD

646-608-8033rochlind@mskcc.org

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Danielle Rochlin, MD

646-608-8033

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Danielle Rochlin, MD

646-608-8033

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Danielle Rochlin, MD

646-608-8033

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Danielle Rochlin, MD

646-608-8033

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Danielle Rochlin, MD

646-608-8033

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Danielle Rochlin, MD

646-608-8033

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Breast Tissue Expander Placement
  • Stimulan Rapid Cure
  • Local Antibiotic Delivery
  • Prevent Infection
  • 25-278

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-10.