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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cefazolin Injection
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de Québec - Université Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibiotics

No antibiotics

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with surgical site infection in each group
1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion)

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
March 25, 2021
Sponsor
CHU de Quebec-Universite Laval
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1. Study Identification

Unique Protocol Identification Number
NCT04818931
Brief Title
Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy
Official Title
Does a Preoperative Prophylactic Antibiotic Reduce Surgical Site Infection Following Wire-localized Lumpectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
Cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy
Arm Title
No antibiotics
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Cefazolin Injection
Intervention Description
cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy
Primary Outcome Measure Information:
Title
Number of participants with surgical site infection in each group
Description
1) patient had positive wound cultures; or 2) required abscess drainage; or 3) received antibiotic treatment for breast symptoms (e.g., swelling, erythema, congestion)
Time Frame
within 30 days after operation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU de Québec - Université Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34825283
Citation
Giguere GB, Poirier B, Provencher L, Boudreau D, Leblanc D, Poirier E, Hogue JC, Morin C, Desbiens C. Do Preoperative Prophylactic Antibiotics Reduce Surgical Site Infection Following Wire-Localized Lumpectomy? A Single-Blind Randomized Clinical Trial. Ann Surg Oncol. 2022 Apr;29(4):2202-2208. doi: 10.1245/s10434-021-11031-9. Epub 2021 Nov 25.
Results Reference
derived

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

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