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

NCT04818931 | Completed

• 1 other identifier: 2018-4107
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  within 30 days after operation

Study Arms (2)

Antibiotics

EXPERIMENTAL

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

Drug: Cefazolin Injection

No antibiotics

NO INTERVENTION

Interventions

Cefazolin Injection DRUG

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

Antibiotics

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

CHU de Québec - Université Laval

Québec, Quebec, G1S4L8, Canada

Location

Related Publications (1)

• 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.

  PMID: 34825283 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: April 7, 2018
• Primary Completion: June 10, 2019
• Study Completion: December 10, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)