Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Surgical Site Infections

Treatments: Drug: Short antibiotic course (standard of care); Drug: Prolonged antibiotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02012517

0447-13-SMC

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 -

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

short antibiotic course

Active Comparator group

Description:

Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery

Treatment:

Drug: Short antibiotic course (standard of care)

Prolonged antobiotic treatment

Experimental group

Description:

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

Treatment:

Drug: Prolonged antibiotic treatment