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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-07

Study Completion Date

2019-12-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Antibiotics

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

Group Type EXPERIMENTAL

Cefazolin Injection

Intervention Type DRUG

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

No antibiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefazolin Injection

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No