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NCT07339215 · ClinicalTrials.gov registry record · NA
Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction
A NA study, sponsored by University of California, Davis.
- Not yet
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT07339215: Clinical Trial NA study, sponsored by University of California, Davis.
NCT07339215 is a NA study that has not yet begun recruiting, run by University of California, Davis. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07339215, a NA study, has not yet begun recruiting, sponsored by University of California, Davis.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Antibiotic loaded calcium sulfate beads
- DEVICE Polymethylmethacrylate antibiotic disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2027-12 |
| Phase | NA |
What is known before NCT07339215 opens enrollment
NCT07339215 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Antibiotic loaded calcium sulfate beads is the first listed.
NCT07339215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07339215 about?
NCT07339215 is a clinical study titled "Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction". 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...
What is the current status of trial NCT07339215?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2026-07-01. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07339215?
The interventions under investigation include: Antibiotic loaded calcium sulfate beads (DEVICE), Polymethylmethacrylate antibiotic disc (DEVICE).
Who is sponsoring clinical trial NCT07339215?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07339215's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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