Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction

NCT07339215 | Not Yet Recruiting FDA Device

• 1 other identifier: 2369088
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tissue Expander Based Breast Reconstruction

Keywords

breast reconstruction; Tissue Expander Breast Reconstruction; Tissue Expander; Surgical Site Infection; Periprosthetic Infection; Local antibiotics; PMMA antibiotic disc

Outcome Measures

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.

  Perioperative/Periprocedural

Secondary Outcomes (4)

• Surgical site infection rate

  Perioperative/Periprocedural

• Tissue expander loss

  Perioperative/Periprocedural

• Peak antibiotic concentration (Cmax)

  Perioperative/Periprocedural

• Any postoperative complication (non-infectious)

  Perioperative/Periprocedural

Study Arms (2)

PMMA Antibiotic Disc

EXPERIMENTAL

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.

Device: Polymethylmethacrylate antibiotic disc

Absorbable Antibiotic Beads

ACTIVE COMPARATOR

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.

Device: Antibiotic loaded calcium sulfate beads

Interventions

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.

PMMA Antibiotic Disc

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.

Absorbable Antibiotic Beads

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed).
• Able to consent and comply with follow-up/aspiration visits.

You may not qualify if:

• 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
• Pregnancy, planning to become pregnant during the study, or lactation.
• Lack of capacity to provide consent.
• Prisoners

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ara A Salibian, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either an antibiotic-impregnated PMMA disc or absorbable antibiotic beads placed in the breast pocket at the time of tissue expander reconstruction. Each participant remains in their assigned group for the duration of the study, with no crossover between arms.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)