Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction

Starting soon · Not applicable

Conditions studied: Tissue Expander Based Breast Reconstruction

In brief

Infections after tissue expander breast reconstruction can lead to pain, additional surgeries, and loss of the reconstruction. This study will compare two types of antibiotic carriers used during surgery to help lower the risk of infection. One carrier is a non-absorbable PMMA disc, and the other is an absorbable antibiotic bead. Both release antibiotics directly into the breast pocket after surgery. About 100 patients will be randomly assigned to receive one of these two carriers at the time of tissue expander placement. After surgery, small samples of fluid around the tissue expander will be collected during routine clinic visits. These samples will be tested to measure how much antibiotic is present over time. The study will also track infections, tissue expander loss, and other complications during the first 90 days after surgery. The goal is to learn how much antibiotic each carrier delivers and whether one method is more effective at preventing infection.

Key facts

Study ID

NCT07339215

Run by

University of California, Davis

People needed

100

Starts

2026-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed).
• Able to consent and comply with follow-up/aspiration visits.

You may not qualify if…

• Allergy to vancomycin, tobramycin, or PMMA components.
• CKD stage 4-5 (eGFR <30 mL/min/1.73m²).
• Chronic immunosuppression (≥10 mg prednisone daily or biologic immunosuppressants).
• Active systemic infection
• Pregnancy, planning to become pregnant during the study, or lactation.
• Lack of capacity to provide consent.
• Prisoners

Where it is running

• UC Davis Medical Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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