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Antibiotics and Tissue Expanders in Breast Reconstruction

This study has been withdrawn prior to enrollment.
(The study was withdrawn prior to IRB approval.)
Information provided by (Responsible Party):
Grant Carlson, Emory University Identifier:
First received: July 11, 2013
Last updated: February 22, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    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 ]

Enrollment: 0
Anticipated Study Start Date: June 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01899690

Sponsors and Collaborators
Emory University
Principal Investigator: Grant W Carlson, MD Emory University
  More Information

Responsible Party: Grant Carlson, Professor, Emory University Identifier: NCT01899690     History of Changes
Other Study ID Numbers: IRB00063849
Study First Received: July 11, 2013
Last Updated: February 22, 2017

Keywords provided by Emory University:
breast reconstruction
surgical site infection
plastic surgery

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Pathologic Processes
Wound Infection
Postoperative Complications
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on April 25, 2017