This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic
delivery:
Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug
Administration (FDA) has approved our Investigational New Drug (IND) application to conduct
this RCT. An IND application was necessary because subcutaneous injection of antibiotics in
general, and cefazolin and metronidazole in particular are considered to be "off-label". In
addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a
dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate
(10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also
considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an
over-the-needle subcutaneous catheter specifically designed to deliver relatively large
volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and
efficacy of the HK SubQKath