Antibiotic Carriers in Breast Reconstruction
This study is for women having breast reconstruction with tissue expanders. Infections can be a problem after this surgery, so researchers are comparing two ways to deliver antibiotics directly to the surgical area. You would receive either absorbable beads containing vancomycin and tobramycin, or a non-absorbable disc also with vancomycin and tobramycin. Both are placed during surgery and release antibiotics over time. The study aims to see which method provides better antibiotic levels in the breast pocket. About 100 women will participate, and fluid samples will be taken after surgery to measure antibiotic levels. The study is currently recruiting.
- Study design
- This is an interventional study where about 100 participants will be randomly assigned to receive one of two antibiotic carriers. The phase of the study is not specified.
- What's involved
- You would undergo tissue expander breast reconstruction surgery and have small fluid samples collected from around the tissue expander during routine clinic visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Antibiotic exposure will be measured for up to 4 weeks after surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ara A Salibian, MD · PRINCIPAL_INVESTIGATOR · University of California, Davis
Who to contact
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What this trial measures
- Local antibiotic exposure (log-transformed AUC₀-₄ weeks)Perioperative/Periprocedural
Vancomycin and tobramycin concentrations will be measured in periprosthetic seroma fluid collected during routine postoperative visits. The primary endpoint is the log-transformed area under the concentration-time curve from week 0 to week 4 (AUC₀-₄ weeks), which will be compared between the PMMA disc and absorbable bead groups. This will be measured weekly from tissue expander placement (baseline), and weekly at each tissue expander fill until tissue expander exchange at 4 weeks.