A Prospective Randomized Trial of Local Antibiotic Carriers in Tissue Expander-Based Breast Reconstruction
University of California, Davis
Summary
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.
Description
Infection remains a devastating complication in tissue expander-based breast reconstruction, potentially causing patient distress, multiple re-operations, explantation, and the failure of the entire reconstructive process. A promising strategy to reduce this risk involves the local application of antibiotic carriers-materials placed in the surgical pocket that elute high concentrations of antibiotics directly at the site where infections begin. Recent studies have shown that both non-absorbable polymethylmethacrylate (PMMA) discs and absorbable antibiotic beads can significantly lower infectio…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed). 2. Able to consent and comply with follow-up/aspiration visits. Exclusion Criteria: 1. Allergy to vancomycin, tobramycin, or PMMA components. 2. CKD stage 4-5 (eGFR \<30 mL/min/1.73m²). 3. Chronic immunosuppression (≥10 mg prednisone daily or biologic immunosuppressants). 4. Active systemic infection 5. Pregnancy, planning to become pregnant during the study, or lactation. 6. Lack of capacity to provide consent. 7. Prisoners
Interventions
- DeviceAntibiotic loaded calcium sulfate beads
Absorbable antibiotic beads containing vancomycin and tobramycin will be placed in the breast pocket at the time of tissue expander reconstruction. The beads dissolve gradually and release antibiotics directly into the periprosthetic space. This intervention allows comparison of antibiotic exposure, infection rates, and tissue expander complications relative to the non-absorbable PMMA disc.
- DevicePolymethylmethacrylate antibiotic disc
A non-absorbable polymethylmethacrylate (PMMA) disc containing vancomycin and tobramycin will be placed in the breast pocket at the time of tissue expander reconstruction. The disc is molded intraoperatively and designed to elute high local concentrations of antibiotics into the periprosthetic space. This intervention is intended to reduce early postoperative infection risk and allow pharmacokinetic sampling of antibiotic levels in seroma fluid during routine postoperative visits.
Location
- UC Davis Medical CenterSacramento, California