Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Study Overview
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Brief Summary
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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.

Official Title
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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Drug: Prolonged antibiotic treatment
* Drug: Short antibiotic course (standard of care)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All criteria should be present: Signing an informed consent form Reconstructive breast surgery One drain or more remained after surgery - 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: short antibiotic course<br>Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery | Drug: Short antibiotic course (standard of care)<br> <br> * Other names: Intravenous cefazolin 2 grams every 8 hours for 24 hours starting at surgery;|
| Experimental: Prolonged antobiotic treatment<br>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 | Drug: Prolonged antibiotic treatment<br> <br> * Other names: Intravenous cefazolin 2 grams every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection | 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical site infection, breast reconstruction, drains, prophylaxis