Antibiotics and Tissue Expanders in Breast Reconstruction

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.

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.