Trials Sponsors Conditions Drugs Pricing

Brief Summary

The goal of this clinical trial is to determine whether preoperative antibiotic prophylaxis with cefazolin is necessary to prevent surgical site infections in adult women undergoing breast-conserving surgery (lumpectomy or partial mastectomy) for breast cancer. Specifically, the trial aims to establish whether surgery without antibiotic prophylaxis is non-inferior to surgery with cefazolin prophylaxis in terms of surgical site infections within 30 days after surgery. The main questions it aims to answer are:

Is the rate of surgical site infections within 30 days after surgery without antibiotic prophylaxis non-inferior to that observed with cefazolin prophylaxis?
How does surgery without antibiotic prophylaxis affect postoperative complications, including antibiotic-related adverse events, and the subsequent management of surgical site infections? Researchers will compare preoperative cefazolin prophylaxis (2 g administered intravenously) with placebo (0.9% saline solution) to determine whether surgery without antibiotic prophylaxis is non-inferior to surgery with cefazolin prophylaxis in preventing surgical site infections. A total of 1,600 participants will be randomly assigned to one of the two groups. Neither the participants nor the healthcare professionals involved in their care will know which treatment has been administered. Participants will:
Undergo breast-conserving surgery for breast cancer, with or without a sentinel lymph node procedure, as part of their usual care.
Receive a single intravenous administration of either cefazolin or placebo before the surgical incision.
Receive information about the signs and symptoms of surgical site infections and how to contact the study team if an infection is suspected.
Be contacted by telephone approximately 15 and 30 days after surgery to assess the occurrence of surgical site infections and other postoperative complications. No additional hospital visits are required specifically for the study.

Conditions

Breast Cancer Breast Surgery Surgical Site Infection (SSI)Surgical Site Infection Prevention

Keywords

Breast-Conserving SurgeryLumpectomySurgical antibiotic prophylaxisSurgical antimicrobial prophylaxisCefazolinSurgical site infection

Outcome Measures

Primary Outcomes (1)

Proportion of patients with any surgical site infection (SSI)
within 30 days after surgery

Secondary Outcomes (11)

Proportion of patients with superficial SSI and deep SSI
within 30 days after surgery
Proportion of SSI among patients operated on for simple lumpectomy and for lumpectomy combined with a sentinel lymph node procedure
within 30 days after surgery

Study Arms (2)

Cefazolin

EXPERIMENTAL

Administration of preoperative surgical antibiotic prophylaxis with cefazolin

Drug: Cefazolin 2 g Infusion

Placebo

PLACEBO COMPARATOR

Administration of a placebo identical in appearance to the cefazolin preparation, without antibiotic prophylaxis.

Drug: Placebo infusion of .9 normal saline

Interventions

Cefazolin 2 g InfusionDrug

Cefazolin 2 g diluted in 100 mL of 0.9% sodium chloride solution, administered intravenously within one hour before surgical incision. An additional dose of 1 g may be administered if surgery lasts more than 4 hours.

Cefazolin

Placebo infusion of .9 normal salineDrug

100 mL of 0.9% sodium chloride solution, administered intravenously within one hour before surgical incision. An additional 100 mL may be administered if surgery lasts more than 4 hours. The placebo is indistinguishable from the cefazolin preparation.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
CEFAZOLINE VIATRIS 2 g, poudre pour solution injectable (IM-IV)
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
Cefazoline Viatris 1 g poudre pour solution injectable ou pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

CEFAZOLINE VIATRIS 2 g, poudre pour solution injectable (IM-IV)
Named ingredient: Cefazolin sodium
View registry record
Cefazoline Viatris 1 g poudre pour solution injectable ou pour perfusion
Named ingredient: Cefazolin sodium
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients (≥18 years).
Undergoing breast lumpectomy/partial mastectomy for breast cancer, with or without sentinel lymph node procedure.

Sponsors & Collaborators

University Hospital, Clermont-Ferrand
Otherlead
University Hospital Of Clermont-Ferrand
Type not reportedlead

Study Sites (33)

Hôpital Privé de Provence

Aix-en-Provence, France

Lise LaclautreCONTACTpromo_interne_drci@chu-clermontferrrand.fr

Olivier RuinetPRINCIPAL INVESTIGATOR

CHU Amiens Picardie (site Sud)

Amiens, France

Lise LaclautreCONTACTpromo_interne_drci@chu-clermontferrand.fr

Stéphane BarPRINCIPAL INVESTIGATOR

Clinique Victor Pauchet

Amiens, France

Lise LaclautreCONTACT

MeSH Terms

Conditions

Breast NeoplasmsSurgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Study Officials

Marc Garnier, MD, PhD
University Hospital, Clermont-Ferrand
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 (0)4.73.75.49.63 promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 21, 2026

First Posted

October 27, 2026

Study Start

November 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

November 2028

Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Cefazolin

Placebo

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Cefazolin

Placebo

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations