Trials / Recruiting
RecruitingNCT07220967
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
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 392 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tissue Expander (TE) | Tissue Expander (TE) |
| DRUG | Vancomycin and Gentamicin | Given through Stimulan Rapid Cure during surgery |
| DEVICE | Stimulan Rapid Cure | Vancomycin and Gentamicin given through Stimulan Rapid Cure during surgery |
Timeline
- Start date
- 2025-10-21
- Primary completion
- 2027-10-01
- Completion
- 2027-10-01
- First posted
- 2025-10-27
- Last updated
- 2026-04-09
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07220967. Inclusion in this directory is not an endorsement.