Antibiotic Carriers for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ara A Salibian, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for adult women over 18 who are having breast reconstruction with tissue expanders, either right away or after some time. They must be able to give consent and attend follow-up visits where fluid samples will be taken from around the tissue expander.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Treatment
Participants undergo tissue expander placement with either a PMMA disc or absorbable antibiotic beads
Postoperative Monitoring
Antibiotic concentrations are measured in seroma fluid during routine clinic visits
Follow-up
Participants are monitored for surgical site infections, tissue expander loss, and other complications
What Are the Treatments Tested in This Trial?
Interventions
- Antibiotic loaded calcium sulfate beads
- Polymethylmethacrylate antibiotic disc
Trial Overview
The study compares two types of antibiotic carriers: a non-absorbable PMMA disc and an absorbable antibiotic bead. Both are used during surgery to reduce infection risk by releasing antibiotics into the breast area. The effectiveness of each method in preventing infections will be monitored.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this arm will receive a non-absorbable PMMA disc containing vancomycin and tobramycin placed in the breast pocket at the time of tissue expander reconstruction.
Participants in this arm will receive absorbable antibiotic beads containing vancomycin and tobramycin placed in the breast pocket at the time of tissue expander reconstruction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
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