Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction

Conditions

• Tissue Expander Based Breast Reconstruction

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Dec 2025

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PMMA Antibiotic Disc
  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.
• Active Comparator: Absorbable Antibiotic Beads
  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.

Primary Outcome Measure

Local antibiotic exposure (log-transformed AUC₀-₄ weeks) [ Time Frame: Perioperative/Periprocedural ]

Locations (1)

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