Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Phase 4

• Conditions: Surgical Site Infections
• Interventions: Drug: Short antibiotic course (standard of care); Drug: Prolonged antibiotic treatment

• Registration Number: NCT02012517
• Lead Sponsor: Sheba Medical Center

Brief Summary

The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-13
• Last Update Submitted: 2013-12-13
• Study First Posted: 2013-12-16
• Last Update Posted: 2013-12-16
• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

All criteria should be present:

1. Signing an informed consent form
2. Reconstructive breast surgery
3. One drain or more remained after surgery -

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Exclusion Criteria

Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
short antibiotic course	Short antibiotic course (standard of care)	Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery
Prolonged antobiotic treatment	Prolonged antibiotic treatment	Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains

Primary Outcome Measures

Name	Time	Method
surgical site infection	1 year	The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups

Trial Locations

Locations (1)

Department of plastic surgery, Sheba medical center; 🇮🇱 Tel Hashomer, Israel