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Antibiotics and Tissue Expanders in Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT01899690
Recruitment Status : Withdrawn (The study was withdrawn prior to IRB approval.)
First Posted : July 15, 2013
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Grant Carlson, Emory University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Complications; Breast Prosthesis, Infection or Inflammation Drug: antibiotic Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Prophylactic Perioperative Antibiotic Administration on Surgical Site Infections Following Implant-based Breast Reconstruction.
Estimated Study Start Date : June 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: one year ]
    Surgical site infection (as defined by CDC consensus guidelines) up to 1 year after implant-based breast reconstruction


Secondary Outcome Measures :
  1. Surgical site infection requiring implant/expander removal [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899690


Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Grant W Carlson, MD Emory University
More Information
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Responsible Party: Grant Carlson, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01899690     History of Changes
Other Study ID Numbers: IRB00063849
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Inflammation
Surgical Wound Infection
Pathologic Processes
Wound Infection
 Postoperative Complications
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents