Clinical trial · Interventional
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
A Randomized Controlled Trial to Determine the Efficacy of Local Antibiotic Delivery in the Prevention of Breast Tissue Expander-Associated Infections
NCT07220967CI-TRIAL-00117592recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The researchers are doing this study to find out whether Stimulan Rapid Cure works to reduce the risk of infections in people getting tissue expanders placed during mastectomy. The researchers will also study whether Stimulan Rapid Cure affects the risk of seroma, a possible complication of surgery that involves fluid buildup under the skin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stimulan Rapid Cure | Device | — | UNRESOLVED |
| Tissue Expander (TE) | Procedure | — | UNRESOLVED |
| Vancomycin and Gentamicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients randomized to Tissue Expander (TE) + antibiotic beads
- interventionNames
- Procedure: Tissue Expander (TE)
- Drug: Vancomycin and Gentamicin
- Device: Stimulan Rapid Cure
- type
- ACTIVE_COMPARATOR
- label
- Patients randomized to Tissue Expander (TE) only
- interventionNames
- Procedure: Tissue Expander (TE)
Primary outcomes (2)
- measure
- Surgical site infections (SSI) incidence (cohort PatientsTissue Expander (TE) + antibiotic beads)
- timeFrame
- within 90 days postoperatively
- description
- The researchers define SSI as clinically evident local signs or symptoms of infection (e.g., breast erythema, swelling, and/or warmth without an alternative etiology \[seroma, radiation\]; purulent drainage; aspirate with positive cultures), with or without systemic signs or symptoms (e.g., fever, leukocytosis), that occur within 90 days postoperatively
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female sex * Aged 18 years or older * Planned to undergo mastectomy for breast cancer, genetic predisposition to and/or strong family history of breast cancer, or other prophylactic indication * Planned to undergo unilateral or bilateral immediate breast reconstruction (i.e., reconstruction at the time of mastectomy) with prepectoral TE placement at MSK * BMI less than 40 kg/m2 * Not actively smoking or using other nicotine products within 6 weeks of surgery * No contraindications to Stimulan antibiotic bead placement: hypercalcemia, severe vascular or neurological disease, uncontrolled diabetes, pregnancy, and severe degenerative bone disease * No known allergy to calcium sulfate, vancomycin, or gentamicin * No impaired decision-making capacity
References
Publications (0)
Data not yet available
No reference posted for this study.