Trial record 5 of 22 for:    "Breast Implants" | Open Studies

Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Yasmin Maor, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02012517
First received: December 5, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Surgical Site Infections
Drug: Prolonged antibiotic treatment
Drug: Short antibiotic course (standard of care)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • surgical site infection [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 160
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012517

Contacts
Contact: Yasmin Maor, MD yasmin.maor@sheba.health.gov.il

Locations
Israel
Department of plastic surgery, Sheba medical center Not yet recruiting
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Yasmin Maor, MD Sheba Medical Center
  More Information

No publications 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     History of Changes
Other Study ID Numbers: 0447-13-SMC
Study First Received: December 5, 2013
Last Updated: December 13, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
surgical site infection
breast reconstruction
drains
prophylaxis

Additional relevant MeSH terms:
Infection
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 30, 2014