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NCT Number: NCT07220967

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)

    Time frame: within 90 days postoperatively

    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

  2. Surgical site infections (SSI) incidence (cohort Patients randomized to Tissue Expander (TE) only)

    Time frame: within 90 days postoperatively

    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

Secondary outcomes

  1. Compare the rates of seroma (cohort PatientsTissue Expander (TE) + antibiotic beads)

    Time frame: 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.

  2. Compare the rates of seroma (cohort Patients randomized to Tissue Expander (TE) only)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Babak Mehrara, MD

CONTACT

646-608-8639

Danielle Rochlin, MD

CONTACT

[email protected]

646-608-8033

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 27, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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