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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

NCT02012517 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-12-16

No results posted yet for this study

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.

Conditions

  • Surgical Site Infections

Interventions

DRUG

Prolonged antibiotic treatment

DRUG

Short antibiotic course (standard of care)

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Yasmin Maor, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02012517 on ClinicalTrials.gov