Antibiotics and Tissue Expanders in Breast Reconstruction

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Grant Carlson, Emory University
ClinicalTrials.gov Identifier:
NCT01899690
First received: July 11, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This study is a randomized controlled non-blinded double arm study examining the effect of routine postoperative oral antibiotic therapy in preventing postoperative surgical site infections after breast reconstruction. The investigators hypothesize that use of prophylactic antibiotics after breast reconstruction does not reduce surgical site infections.


Condition Intervention Phase
Complications; Breast Prosthesis, Infection or Inflammation
Drug: antibiotic
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: Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction.

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: one year ] [ Designated as safety issue: No ]
    Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction


Secondary Outcome Measures:
  • Surgical site infection requiring implant/expander removal [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: October 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antibiotic
7 days of preventive antibiotics after surgery
Drug: antibiotic
Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.
Other Names:
  • cephalexin (Keflex)
  • clindamycin
  • bactrim
  • (in order of choice pending relevant allergies)
No Intervention: No antibiotic
No preventive postoperative antibiotics

Detailed Description:

Surgical site infections occur in up to one-third of patients who undergo implant-based breast reconstruction following mastectomy for cancer; most of such cases require subsequent prosthetic removal. This elevated risk relative to other surgical procedures and patient populations has been attributed to cancer-related immunocompromise, foreign body placement, postoperative drainage tube maintenance, and chemoradiotherapy administration. The use of extended postoperative prophylactic antibiotics is prevalent amongst plastic surgeons despite lack of evidence supporting efficacy of such practice. Further, the National Surgical Care Initiative Project (SCIP) as sponsored by the Centers for Medicare & Medicaid Services (CMS) mandates discontinuation of antibiotics by 24 hours after surgery, as further extension not only fails to reduce infection risk in the general surgical population, but also may contribute to bacterial resistance. The primary objective of this study is to compare the risk of surgical site infection in implant-reconstruction patients who receive extended prophylactic antibiotics with those who do not. In this randomized-controlled trial, women at a single institution who undergo implant-based breast reconstruction will be assigned to receive either less than 24 hours or 7 days of prophylactic postoperative antibiotics. Primary outcome measures will include development of superficial incisional, deep incisional, and organ/space surgical site infections at one year as defined by the Centers for Disease Control (CDC). Following adjustment for patient age, body mass index, comorbid disease, reconstructive timing, disease stage, adjuvant therapy, implant volume, drain use, and other procedural variables, relative risk of postoperative infection with use of extended prophylactic antibiotics will be estimated. Secondary outcome measures will include prosthetic explantation and, in cases of infection, bacteriology and antibiotic susceptibilities.

  Eligibility

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

Inclusion Criteria:

  • Patients in whom implant-based breast reconstruction is selected based on clinician recommendation, patient agreement, and mutual consensus.
  • Ability to understand the purposes and risks of the study and willingly give standard written informed consent for treatment established by Emory University Hospital and affiliates.

Exclusion Criteria:

  • Pregnancy
  • Incarceration
  • Non-implant based reconstructive plan
  • Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
  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: NCT01899690

Contacts
Contact: Grant W Carlson, MD 404-778-5233 gcarlso@emory.edu
Contact: Carrie K Chu, MD 770-402-4649 kcchu@emory.edu

Locations
United States, Georgia
Emory University School of Medicine Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Grant Carlson, MD    404-778-5233    gcarlso@emory.edu   
Principal Investigator: Grant Carlson, MD         
Sub-Investigator: Carrie Chu, MD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Grant W Carlson, MD Emory University
  More Information

No publications provided

Responsible Party: Grant Carlson, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01899690     History of Changes
Other Study ID Numbers: IRB00063849
Study First Received: July 11, 2013
Last Updated: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
breast reconstruction
cancer
expander
antibiotics
infection
surgical site infection
surgery
oncology
plastic surgery

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Clindamycin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014