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Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction

ConditionTissue Expander Based Breast Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Davis

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed).

Able to consent and comply with follow-up/aspiration visits.

Disqualifiers

Allergy to vancomycin, tobramycin, or PMMA components.

CKD stage 4-5 (eGFR <30 mL/min/1.73m²).

Chronic immunosuppression (≥10 mg prednisone daily or biologic immunosuppressants).

Active systemic infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Antibiotic loaded calcium sulfate beads

    Device

    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.

  • Polymethylmethacrylate antibiotic disc

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PMMA Antibiotic DiscExperimental treatment 1 intervention
Group B: Absorbable Antibiotic BeadsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Local antibiotic exposure (log-transformed AUC₀-₄ weeks)

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.

Time frame
Perioperative/Periprocedural

Secondary outcomes

1

Surgical site infection rate

Infections will be defined using CDC criteria. A blinded adjudication committee will review all suspected cases. The incidence of infection within 90 days after tissue expander placement will be compared between arms.

Time frame
Perioperative/Periprocedural
2

Tissue expander loss

Tissue expander loss is defined as explantation due to infection, wound breakdown, or other complications. The proportion of patients requiring explantation within 90 days of surgery will be compared between groups.

Time frame
Perioperative/Periprocedural
3

Peak antibiotic concentration (Cmax)

Antibiotic concentrations of aspirated Seroma fluid will be measured at the time of tissue expander placement (baseline), and weekly there-after at the time of tissue expander fills from week 1 to week 4. The highest measured vancomycin and tobramycin concentrations in periprosthetic fluid samples will be recorded for each participant during the study period. Cmax will be compared between the two study arms.

Time frame
Perioperative/Periprocedural
4

Any postoperative complication (non-infectious)

Complications including seroma requiring aspiration, hematoma, skin necrosis, dehiscence, or unplanned return to the operating room within 90 days will be documented and compared between groups.

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: