Last reviewed · How we verify
NCT04818931
Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy
NA trial testing Cefazolin Injection in Breast Cancer in 326 participants. Completed in 10 December 2019.
10 June 2019
Quick facts
| Lead sponsor | CHU de Quebec-Universite Laval |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 326 |
| Start date | 7 April 2018 |
| Primary completion | 10 June 2019 |
| Estimated completion | 10 December 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Cefazolin Injection — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
CHU de Quebec-Universite Laval — full company profile →
Who can join
Eligibility, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Data on the benefits of preoperative prophylactic antibiotics for breast surgery are conflicting and there is no guideline for their use for wire-localized lumpectomy. The aims of this study were to determine whether a single dose of pre-operative antibiotic reduces surgical site infection (SSI) for wire-localized lumpectomy and to identify risk factors for SSI. Methods: This was a prospective randomized trial carried out from April 2018 to June 2019 at the "Centre des Maladies du Sein du CHU de Québec - Université Laval", a tertiary center specialized in breast surgery. After informed consent, patients who underwent wire-localized lumpectomy were randomized to receive or not a pre-operative single dose of prophylactic antibiotic (cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy). Data regarding demographics, comorbidities, perioperative details, and SSI were analyzed. SSI was considered if: 1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion) within 30 days after operation, in the absence of wound culture or in the presence of negative results. The patients and the investigator responsible for data collection were blind to grouping. All patients were called 30 days after surgery to be sure that they did not consult at another hospital for surgical wound infection.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Do Preoperative Prophylactic Antibiotics Reduce Surgical Site Infection Following Wire-Localized Lumpectomy? A Single-Blind Randomized Clinical Trial.
Giguère GB, Poirier B, Provencher L, Boudreau D, et al · · 2022 · cited 6× · PMID 34825283 · DOI 10.1245/s10434-021-11031-9 -
Microorganisms and Breast Cancer: An In-Depth Analysis of Clinical Studies.
Naderi N, Mosahebi A, Williams NR. · · 2023 · cited 2× · PMID 38276152 · DOI 10.3390/pathogens13010006
Verify or expand the search:
- PubMed search for NCT04818931
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
- NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
- NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
- NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
- NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
- NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting
Other CHU de Quebec-Universite Laval trials
Trials by the same sponsor.
- NCT07067827 — Self-questionnaire in Osteoporosis · recruiting
- NCT06018116 — A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. · Phase 2 · withdrawn
- NCT05941806 — Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection · Phase 3 · unknown
- NCT06351176 — Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes · enrolling by invitation
- NCT05859139 — Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13 · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04818931 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHU de Quebec-Universite Laval
- Last refreshed: 29 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04818931.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing