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PROPHY-SEIN - Evaluation of the effect of antibiotic prophylaxis during lumpectomy for breast cancer: prospective randomised double-blind noninferiority study of placebo vs cefazolin
EU CTIS ID: 2025-525020-99-00
What this study is testing
To demonstrate the non-inferiority of placebo compared with SAP using cefazolin, administered in a double-blind fashion in the hour preceding the start of breast lumpectomy/partial mastectomy surgery for cancer, in terms of incidence of any surgical site infection within 30 days of surgery (“D30”).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients (≥18 years).
- Undergoing breast lumpectomy/partial mastectomy with or without sentinel lymph node procedure
- Patients benefiting from a Social Security system.
- Having given their informed consent
You likely can't join if
- Patients undergoing breast lumpectomy/partial mastectomy with concomitant complete axillary lymph node dissection.
- Known hypersensitivity to cefazolin or other beta-lactams.
- Patients with extremely severe obesity (BMI >50 kg/m2).
- Active bacterial infection treated with antibiotics at the time of surgery or recent antimicrobial therapy (in the 15 days prior to surgery).
- Patients with severe immunosuppression or a combination of other risk factors for SSI, which would lead the attending anaesthesiologist and surgeon to decide to administer surgical antimicrobial prophylaxis on an individual basis, outside the national guidelines.
- Participation to another clinical trial aimed at reducing SSI.
See the full eligibility criteria
- Adult patients (≥18 years).
- Undergoing breast lumpectomy/partial mastectomy with or without sentinel lymph node procedure
- Patients benefiting from a Social Security system.
- Having given their informed consent
- Patients undergoing breast lumpectomy/partial mastectomy with concomitant complete axillary lymph node dissection.
- Known hypersensitivity to cefazolin or other beta-lactams.
- Patients with extremely severe obesity (BMI >50 kg/m2).
- Active bacterial infection treated with antibiotics at the time of surgery or recent antimicrobial therapy (in the 15 days prior to surgery).
- Patients with severe immunosuppression or a combination of other risk factors for SSI, which would lead the attending anaesthesiologist and surgeon to decide to administer surgical antimicrobial prophylaxis on an individual basis, outside the national guidelines.
- Participation to another clinical trial aimed at reducing SSI.
- Patients previously enrolled in this study
- Pregnant or breastfeeding women (in patients of childbearing age, a pregnancy test is performed before surgery, the results of which will be verified before inclusion in the study).
- Patients benefiting from enhanced protection (minors, adults under legal protection, patients deprived of liberty, etc.).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.