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Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy

Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04818931
Enrollment
326
Registered
2021-03-26
Start date
2018-04-07
Completion date
2019-12-10
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy

Sponsors

CHU de Quebec-Universite Laval
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* \>18 years of age * female * scheduled for a wire-localized lumpectomy

Exclusion criteria

* pregnant or breastfeeding women * incapacity to give informed consent * preoperative breast infection * patients known to be colonized with MRSA * immunocompromised patients * preoperative antibiotic prophylaxis needed for any concomitant condition.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with surgical site infection in each groupwithin 30 days after operation1\) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026