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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04818931
• Other study ID #: 2018-4107
• Status: Completed
• Phase: N/A
• Start date: April 7, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: March 2021
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Surgical Wound Infection

Intervention

Drug:
• Cefazolin Injection
cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy

Locations

Country	Name	City	State
Canada	CHU de Québec - Université Laval	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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