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Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02012517
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
47
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prolonged antibiotic treatment
  • Drug: Short antibiotic course (standard of care)
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: short antibiotic course

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

Drug: Short antibiotic course (standard of care)
Other Names:
  • Intravenous cefazolin 2 grams every 8 hours for 24 hours starting at surgery

    		•
    Experimental: Prolonged antobiotic 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

    Drug: Prolonged antibiotic treatment
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of plastic surgery, Sheba medical center Tel Hashomer Israel 52621

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    • Principal Investigator: Yasmin Maor, MD, Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Yasmin Maor, Head of the infectious didease service to the hospitalized patient, infectious disease unit, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT02012517
    Other Study ID Numbers:
    • 0447-13-SMC
    First Posted:
    Dec 16, 2013
    Last Update Posted:
    Dec 16, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Dr. Yasmin Maor, Head of the infectious didease service to the hospitalized patient, infectious disease unit, Sheba Medical Center
    surgical site infection
    breast reconstruction
    drains
    prophylaxis
    Additional relevant MeSH terms:
    Surgical Wound Infection
    Anti-Bacterial Agents
    Cefazolin
    Cephalexin
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Dec 16, 2013