Tissue Expander Based Breast ReconstructionNCT07339215
Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction
A study testing Antibiotic loaded calcium sulfate beads and Polymethylmethacrylate antibiotic disc in people with Tissue Expander Based Breast Reconstruction, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tissue Expander Based Breast Reconstruction
- What is being tested?
- Antibiotic loaded calcium sulfate beads and Polymethylmethacrylate antibiotic disc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed).
- Able to consent and comply with follow-up/aspiration visits.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
Arman Fijany, MD, 949-351-5830, afijany@health.ucdavis.edu
Ala Mahmoud, MD, 310-465-3336, alamahmoud@health.ucdavis.edu
About this study
Official title: A Prospective Randomized Trial of Local Antibiotic Carriers in Tissue Expander-Based 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 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.
Read the detailed description
Infection remains a devastating complication in tissue expander-based breast reconstruction, potentially causing patient distress, multiple re-operations, explantation, and the failure of the entire reconstructive process. A promising strategy to reduce this risk involves the local application of antibiotic carriers-materials placed in the surgical pocket that elute high concentrations of antibiotics directly at the site where infections begin. Recent studies have shown that both non-absorbable polymethylmethacrylate (PMMA) discs and absorbable antibiotic beads can significantly lower infection rates. However, the current evidence is limited because all prior studies are retrospective, lack direct comparisons between these carriers, and crucially, have no measurements of the actual antibiotic levels achieved in patients. This gap in knowledge leaves surgeons without clear, evidence-based guidance on which method is superior. This study is a prospective, randomized controlled trial designed to provide that definitive evidence. The investigators will enroll 100 patients undergoing tissue expander breast reconstruction at our institution. During surgery, each participant will be randomly assigned to receive either an antibiotic-impregnated PMMA disc or absorbable antibiotic beads placed in the breast pocket alongside the tissue expander. The study is meticulously designed to eliminate bias, with independent experts blinded to the treatment when assessing outcomes. The primary objective is to conduct a detailed pharmacokinetic analysis, measuring the concentration of vancomycin and tobramycin in the periprosthetic fluid over time. This will be achieved by analyzing seroma fluid aspirated during routine, scheduled post-operative clinic visits. This novel approach will not only provide data on whether the carriers work, but also how they work-how high the antibiotic levels reach, and for how long they remain effective. The secondary objective is to compare critical clinical outcomes, including surgical site infection rates, tissue expander loss, and other complications over a 90-day period. By directly linking precise, local drug exposure data with hard clinical endpoints, this research will for the first time establish a biologic gradient for efficacy and determine the comparative effectiveness of these two infection-prevention strategies.
- Being tested
- Antibiotic loaded calcium sulfate beads, Polymethylmethacrylate antibiotic disc
- Keywords
- breast reconstruction, Tissue Expander Breast Reconstruction, Tissue Expander, Surgical Site Infection, Periprosthetic Infection, Local antibiotics, PMMA antibiotic disc
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic loaded calcium sulfate beadsDevice
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 discDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Antibiotic loaded calcium sulfate beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative/Periprocedural
Secondary outcomes (4)
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.
Measured: Perioperative/Periprocedural
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.
Measured: Perioperative/Periprocedural
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.
Measured: Perioperative/Periprocedural
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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Expander Based Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara A Salibian, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339215
- Sponsor's protocol ID
- 2369088
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to the inclusion of sensitive health information and standardized photographs that cannot be fully de-identified. Data will be used solely for the purposes of this study in accordance with UC Davis IRB approval.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Local Antibiotic Carriers in Tissue Expander-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07339215
- Acronym / sponsor ID
- 2369088
- Keywords
- breast reconstruction, Tissue Expander Breast Reconstruction, Tissue Expander, Surgical Site Infection, Periprosthetic Infection, Local antibiotics, PMMA antibiotic disc
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infection remains a devastating complication in tissue expander-based breast reconstruction, potentially causing patient distress, multiple re-operations, explantation, and the failure of the entire reconstructive process. A promising strategy to reduce this risk involves the local application of antibiotic carriers-materials placed in the surgical pocket that elute high concentrations of antibiotics directly at the site where infections begin. Recent studies have shown that both non-absorbable polymethylmethacrylate (PMMA) discs and absorbable antibiotic beads can significantly lower infection rates. However, the current evidence is limited because all prior studies are retrospective, lack direct comparisons between these carriers, and crucially, have no measurements of the actual antibiotic levels achieved in patients. This gap in knowledge leaves surgeons without clear, evidence-based guidance on which method is superior. This study is a prospective, randomized controlled trial designed to provide that definitive evidence. The investigators will enroll 100 patients undergoing tissue expander breast reconstruction at our institution. During surgery, each participant will be randomly assigned to receive either an antibiotic-impregnated PMMA disc or absorbable antibiotic beads placed in the breast pocket alongside the tissue expander. The study is meticulously designed to eliminate bias, with independent experts blinded to the treatment when assessing outcomes. The primary objective is to conduct a detailed pharmacokinetic analysis, measuring the concentration of vancomycin and tobramycin in the periprosthetic fluid over time. This will be achieved by analyzing seroma fluid aspirated during routine, scheduled post-operative clinic visits. This novel approach will not only provide data on whether the carriers work, but also how they work-how high the antibiotic levels reach, and for how long they remain effective. The secondary objective is to compare critical clinical outcomes, including surgical site infection rates, tissue expander loss, and other complications over a 90-day period. By directly linking precise, local drug exposure data with hard clinical endpoints, this research will for the first time establish a biologic gradient for efficacy and determine the comparative effectiveness of these two infection-prevention strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PMMA Antibiotic Disc | Experimental | Device: Polymethylmethacrylate antibiotic discParticipants 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. |
| Absorbable Antibiotic Beads | Active comparator | Device: Antibiotic loaded calcium sulfate beadsParticipants in this arm will receive absorbable antibiotic beads containing vancomycin and tobramycin placed in the breast pocket at the time of tissue expander reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed).
- Able to consent and comply with follow-up/aspiration visits.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic loaded calcium sulfate beadsAbsorbable 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. | Device | Absorbable Antibiotic Beads |
| Polymethylmethacrylate antibiotic discA 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. | Device | PMMA Antibiotic Disc |
Primary outcome
Local antibiotic exposure (log-transformed AUC₀-₄ weeks)
Time frame: Perioperative/Periprocedural
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.
4 secondary outcomes
Surgical site infection rate
Time frame: Perioperative/Periprocedural
Tissue expander loss
Time frame: Perioperative/Periprocedural
Peak antibiotic concentration (Cmax)
Time frame: Perioperative/Periprocedural
Any postoperative complication (non-infectious)
Time frame: Perioperative/Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the inclusion of sensitive health information and standardized photographs that cannot be fully de-identified. Data will be used solely for the purposes of this study in accordance with UC Davis IRB approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ara A Salibian, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic loaded calcium sulfate beads and Polymethylmethacrylate antibiotic disc in people with Tissue Expander Based Breast Reconstruction, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local antibiotic exposure (log-transformed AUC₀-₄ weeks) (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.