Stimulan Rapid Cure for Infection Prevention After Breast Cancer Surgery

Recruiting at 6 trial locations

Overseen By Danielle Rochlin, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Radiation history, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate postoperative period

392 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Stimulan Rapid Cure, an antibiotic treatment, can prevent infections in patients receiving tissue expanders during breast cancer surgery. Researchers aim to determine if it also reduces the risk of seroma, a fluid buildup under the skin post-surgery. Participants will receive either the treatment with antibiotic beads or just the tissue expander. The trial suits women with breast cancer planning immediate reconstruction with tissue expanders who do not smoke or use certain medications. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are actively using steroids or immunosuppressant medication.

What is the safety track record for Stimulan Rapid Cure?

Research has shown that Stimulan Rapid Cure is generally safe for people. Studies have found it reduces the risk of infections during surgeries, such as breast reconstruction. In earlier trials, patients reported few side effects, with most negative reactions being mild. As this treatment is in a phase 4 study, it has already been used safely in other situations. This provides substantial evidence supporting its safety, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Stimulan Rapid Cure because it offers a novel way to prevent infections after breast cancer surgery. Unlike traditional methods that rely solely on systemic antibiotics, this treatment uses antibiotic beads that are placed directly in the surgical area. This local delivery method allows for a higher concentration of antibiotics right where they are needed, potentially reducing the risk of infection more effectively. Additionally, by targeting the infection site directly, it may minimize the side effects associated with systemic antibiotic treatments.

What evidence suggests that Stimulan Rapid Cure might be an effective treatment for infection prevention after breast cancer surgery?

Research has shown that Stimulan Rapid Cure lowers the risk of infections after breast cancer surgery. In this trial, some participants will receive a Tissue Expander (TE) with antibiotic beads. Studies have found that these beads prevent infections by delivering antibiotics directly to the surgical area. This targeted approach ensures antibiotics reach the critical spot, stopping bacteria from causing infections. Clinical data supports that these antibiotic beads enhance standard care, offering extra protection against infections. Overall, Stimulan Rapid Cure has proven effective in preventing infections in breast cancer patients. ^{2 3 4 6 7}

Who Is on the Research Team?

Danielle Rochlin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing mastectomy with tissue expander placement, aiming to prevent post-surgical infections. Specific eligibility details are not provided, but typically participants must be in good health and meet certain criteria related to the condition being treated.

Inclusion Criteria

English speaking

BMI less than 40 kg/m2

No known allergy to calcium sulfate, vancomycin, or gentamicin

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Tissue Expander with antibiotic beads or Tissue Expander only

Immediate postoperative period

Follow-up

Participants are monitored for surgical site infections and seroma formation

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stimulan Rapid Cure

Trial Overview The study is testing whether Stimulan Rapid Cure can reduce infection risk after breast tissue expander placement during mastectomy. It will also assess if this treatment impacts seroma formation, a fluid buildup complication.

How Is the Trial Designed?

Group I: Patients randomized to Tissue Expander (TE) + antibiotic beads Experimental Treatment 3 Interventions

Group II: Patients randomized to Tissue Expander (TE) only Active Control 1 Intervention

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220967

A Study of Antibiotic Delivery to Prevent Infection After ... The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-08028

Local Antibiotic Delivery using the Stimulan Rapid Cure ... This phase IV trial studies how well local antibody delivery using the Stimulan Rapid Cure device works in preventing infections after breast reconstruction ...

3. trialx.com trialx.com/clinical-trials/listings/325303/a-study-of-antibiotic-delivery-to-prevent-infection-after-breast-tissue-expander-placement/?&radius=50

A Study of Antibiotic Delivery to Prevent Infection After ... The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue ...

4. withpower.com withpower.com/trial/phase-4-breast-neoplasms-9-2025-a1b38

Stimulan Rapid Cure for Infection Prevention After Breast ... 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 ...

5. plasticsurgerythemeeting.com plasticsurgerythemeeting.com/programming/program-search/session-details/43730

Scientific Abstract Presentations: Breast Session 1 | PSTM These findings suggest that the beads may serve as an effective adjunct for infection prevention in breast cancer patients by providing localized antibiotic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07220967?lastUpdPost=2020-03-16_

A Study of Antibiotic Delivery to Prevent Infection After ... The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue ...

7. clinconnect.io clinconnect.io/trials/NCT07220967?queryID=9e044a8f92226fc92eff&apos=2

A Study of Antibiotic Delivery to Prevent Infection - ClinConnect The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue ...