Antibiotic Carriers for Breast Reconstruction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to reduce infections after breast reconstruction surgery, which can cause pain and necessitate additional surgeries. It compares two methods of delivering antibiotics directly into the breast area: a non-absorbable PMMA disc (Polymethylmethacrylate antibiotic disc) and absorbable antibiotic beads (Antibiotic-loaded calcium sulfate beads). The study will determine which method delivers more antibiotics and better prevents infections. Women undergoing tissue expander breast reconstruction who can attend follow-up visits might be eligible to participate. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve post-surgical outcomes for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that these antibiotic carriers are safe for use in breast reconstruction?
Studies have shown that both types of antibiotic carriers used in this trial are generally safe. Research indicates that absorbable antibiotic beads are well-tolerated and show promise in preventing infections during high-risk implant surgeries. In a study with 287 patients, only 9.4% of those who received the beads experienced complications, a low rate.
For the non-absorbable PMMA antibiotic disc, research has shown it can safely reduce infection rates in breast reconstruction surgeries. One study found that using these discs resulted in a low rate of complications after surgery and effectively prevented infections.
Both treatments have the potential to reduce infections after breast reconstruction and have good safety records. Participants in this trial can be reassured that these treatments have been tested in similar situations with positive safety outcomes.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they offer innovative ways to deliver antibiotics during breast reconstruction, potentially reducing infection risk. The PMMA antibiotic disc is unique because it is non-absorbable, providing a sustained release of antibiotics like vancomycin and tobramycin directly in the breast pocket. This could mean a longer-lasting protective effect compared to traditional systemic antibiotic treatments. Meanwhile, the absorbable antibiotic beads also release the same antibiotics but dissolve over time, which might reduce the need for removal and decrease long-term foreign material presence. Both treatments aim to improve safety and efficacy compared to standard antibiotic regimens, promising better outcomes for patients undergoing breast reconstruction.
What evidence suggests that this trial's treatments could be effective for preventing infections after breast reconstruction?
Research shows that both absorbable antibiotic beads and non-absorbable PMMA antibiotic discs can help reduce infection rates in breast reconstruction surgeries. In this trial, participants will receive either the PMMA discs or the absorbable antibiotic beads. Studies have found that PMMA discs, which release antibiotics directly at the surgical site, effectively lower infections and have been safely used in similar surgeries. Similarly, absorbable antibiotic beads also release antibiotics and have been used to prevent infections, although one study found no significant difference in infection rates when these beads were used in high-risk patients. Both treatments work by steadily releasing antibiotics in the breast area after surgery to prevent complications. While early evidence supports their potential effectiveness, results can vary depending on individual patient factors.13678
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
Citations
Prophylactic Absorbable Antibiotic Beads for High-risk ...
Findings: There was no significant difference seen in surgical site infection or implant loss in high-risk patients receiving prophylactic ...
Absorbable Antibiotic Bead Prophylaxis for Implant-Based ...
Results. A total of 287 patients were included in the study, of which 27 (9.4%) received antibiotic beads at the time of reconstruction.
Local Antibiotic Concentrations With Tissue Expanders in ...
This study will compare two types of antibiotic carriers used during surgery to help lower the risk of infection. One carrier is a non- ...
4.
journals.lww.com
journals.lww.com/prsgo/fulltext/2023/10000/prophylactic_absorbable_antibiotic_beads_for.42.aspxProphylactic Absorbable Antibiotic Beads for High-risk,...
The purpose of this study was to evaluate the selective use of prophylactic absorbable calcium sulfate antibiotic beads during high-risk implant ...
Prophylactic Antibiotic-Loaded Cement, Absorbable and ...
Antibiotic-loaded cement can be effective for infection prevention in implant-based reconstruction. Nonabsorbable PMMA and absorbable CS for ...
Absorbable Antibiotic Bead Prophylaxis for Implant-Based ...
Outcomes included periprosthetic infection, infection requiring re-operation, and wound-healing complications. Multivariate logistic regression ...
Use of Local Antibiotic Delivery Systems in Tissue ...
The authors reported an infection clearance rate of 82.2% in their treatment group compared with 94.1% in the explantation group (P = .42).
State-of-the-Art Analysis of Antibiotic-Loaded Calcium ...
According to this review, the considered authors have reported promising results with the use of CS beads in multiple conditions related to the ...
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