Tumescent Antibiotic Delivery Pharmacokinetics

Completed · Phase 1

Conditions studied: Prevention of Surgical Site Infections

In brief

Tumescent Antibiotic Delivery (TAD) is a technique for improving the prevention of surgical site infections (SSI). TAD involves the subcutaneous infiltration of tumescent local anesthesia (TLA) containing water soluble antibiotic(s) such as cefazolin and metronidazole. TLA consists of the subcutaneous infiltration of very dilute lidocaine (≤ 1 gram/liter) and epinephrine (≤ 1 milligram/liter) with sodium bicarbonate (10 milliequivalents/liter) in a physiologic solution of sodium chloride which produces intense local anesthesia associated with profound wide-spread vasoconstriction lasting for more than 12 hours. Compared to intravenous antibiotic delivery (IVAD), TAD is expected to produce higher local tissue concentrations of the antibiotic(s) for longer periods of time and lower systemic/serum antibiotic concentrations. This clinical trial will compare TAD to IVAD with respect to pharmacokinetic evidence for possible improved SSI prevention.

Key facts

Study ID

NCT01046981

Run by

Klein, Jeffrey A., M.D.

People needed

4

Starts

2009-03-01

Expected to finish

2011-08-01

Last updated by the study team

2011-09-28

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult
• No allergies to cefazolin, metronidazole or lidocaine

You may not qualify if…

• HIV
• Hepatitis C
• Diabetes

Where it is running

• Capistrano Surgery Center — San Juan Capistrano, California, United States

Full record on ClinicalTrials.gov

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