Trial · NCT07898943
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
NCT07898943, Phase 3, Not yet recruiting, University Hospital, Clermont-Ferrand
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin. Trials, record NCT07898943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
- NCT number
- NCT07898943
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 1,600 participants, estimated
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Conditions
- Breast Cancer, Breast Surgery, Surgical Site Infection (SSI), Surgical Site Infection Prevention
- Interventions
- Cefazolin 2 g Infusion, Placebo infusion of .9 normal saline
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with any surgical site infection (SSI) | within 30 days after surgery | |
| Secondary | Proportion of patients with superficial SSI and deep SSI | within 30 days after surgery | |
| Secondary | 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 | |
| Secondary | Proportion of SSI among patients with and without preoperative localisation of the tumour using a percutaneous device, such as metal wire | within 30 days after surgery | |
| Secondary | Proportion, type and severity of postoperative complications, according to the Clavien and Dindo classification, and the proportion of patients with postoperative sepsis or septic shock | within 30 days after surgery | |
| Secondary | The medical and/or surgical management of any SSI including outpatient/hospital management, local care alone or need for oral/parenteral curative antibiotic therapy, and/or need for revision surgery, need for additional scare or reopening, etc. | Management, even delayed, of any SSI occurring within 30 days after initial surgery | |
| Secondary | Proportion, type and severity (minor, moderate, severe, lethal) of intraoperative and postoperative adverse events potentially attributable to cefazolin or its placebo, and their causality according to the WHO scale | within 30 days after surgery | |
| Secondary | Duration of index hospital stay and whether the index stay had to be prolonged, notably due to the occurrence of a SSI | within 30 days after surgery | |
| Secondary | Need for an unexpected medical or surgical consultation or hospital readmission for a suspected or confirmed SSI | within 30 days after surgery | |
| Secondary | Need for an unexpected admission to the ICU | within 30 days after surgery |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898943
GET https://conductscience.org/api/trials/v1/NCT07898943/registered