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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07220967
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tissue Expander (TE) — PROCEDURE
    Tissue Expander (TE)
  • Vancomycin and Gentamicin — DRUG
    Given through Stimulan Rapid Cure during surgery
  • Stimulan Rapid Cure — DEVICE
    Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery

Study Details

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.

Key Dates

Start date
Oct 21, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
392 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients randomized to Tissue Expander (TE) + antibiotic beads
  • Active Comparator: Patients randomized to Tissue Expander (TE) only

Primary Outcome Measure

Surgical site infections (SSI) incidence [ Time Frame: within 90 days postoperatively ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Danielle Rochlin, MD
[email protected]
646-608-8033
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Danielle Rochlin, MD
646-608-8033
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Danielle Rochlin, MD
646-608-8033
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)CommackNew York11725
Danielle Rochlin, MD
646-608-8033
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Danielle Rochlin, MD
646-608-8033
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Danielle Rochlin, MD
646-608-8033
Memorial Sloan Kettering Nassau (Limited Protocol Activites)Rockville CentreNew York11553
Danielle Rochlin, MD
646-608-8033

Find similar trials in Basking Ridge, NJ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activites)· New York, NY

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