Breast CancerPhase 4NCT07220967
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
A Phase 4 study testing Tissue Expander (TE), Vancomycin and Gentamicin and Stimulan Rapid Cure in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tissue Expander (TE), Vancomycin and Gentamicin and Stimulan Rapid Cure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Oct 2025to Oct 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Babak Mehrara, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Danielle Rochlin, MD, 646-608-8033, rochlind@mskcc.org
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Danielle Rochlin, MD, 646-608-8033
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Danielle Rochlin, MD, 646-608-8033
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Danielle Rochlin, MD, 646-608-8033
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Danielle Rochlin, MD, 646-608-8033
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Danielle Rochlin, MD, 646-608-8033
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Danielle Rochlin, MD, 646-608-8033
About this study
Official title: A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
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
- Being tested
- Tissue Expander (TE), Vancomycin and Gentamicin, Stimulan Rapid Cure
- Keywords
- Breast Tissue Expander Placement, Stimulan Rapid Cure, Local Antibiotic Delivery, Prevent Infection, 25-278
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Expander (TE)Procedure or surgery
Tissue Expander (TE)
Vancomycin and GentamicinDrug
Given through Stimulan Rapid Cure during surgery
Stimulan Rapid CureDevice
Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients randomized to Tissue Expander (TE) + antibiotic beads | Experimental | Not described Receives: Procedure: Tissue Expander (TE); Drug: Vancomycin and Gentamicin; Device: Stimulan Rapid Cure |
| Patients randomized to Tissue Expander (TE) only | Active comparator | Not described Receives: Procedure: Tissue Expander (TE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
The researchers 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
Measured: within 90 days postoperatively
Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only)
The researchers 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
Measured: within 90 days postoperatively
Secondary outcomes (2)
Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads)
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.
Measured: within 90 days postoperatively
Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only)
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.
Measured: within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start21 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Rochlin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220967
- Sponsor's protocol ID
- 25-278
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.