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Tumescent Antibiotic Delivery Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier:
NCT01046981
First received: January 11, 2010
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Prevention of Surgical Site Infections
Procedure: Tumescent Antibiotic Delivery of cefazolin with or without metronidazole
Procedure: Intravenous Antibiotic Delivery
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tumescent Antibiotic Delivery: Pharmacokinetic Evidence for Improved Surgical Site Infection Prevention

Resource links provided by NLM:


Further study details as provided by Klein, Jeffrey A., M.D.:

Primary Outcome Measures:
  • Area Under the Curve (AUC) of antibiotic concentration as a function of time [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4
Study Start Date: March 2009
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tumescent Antibiotic Delivery
TAD followed by sequential serum and interstitial tissue fluid sampling for antibiotic concentration of subsequent 24 hours
Procedure: Tumescent Antibiotic Delivery of cefazolin with or without metronidazole
TAD of cefazolin with or without metronidazole followed by sequential serum and interstitial fluid samples over 14 to 24 hours for antibiotic concentrations
Other Names:
  • Cefazolin
  • Metronidazole
Experimental: Intravenous Antibiotic Delivery
Intravenous antibiotic delivery of cefazolin with or without metronidazole followed by sequential serum and interstitial tissue fluid sampling for antibiotic concentration of subsequent 24 hours.
Procedure: Intravenous Antibiotic Delivery
Intravenous antibiotic delivery of cefazolin with or without metronidazole followed by sequential serum sampling for antibiotic concentration of subsequent 12 to 24 hours.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV
  • Hepatitis C
  • Diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046981

Locations
United States, California
Capistrano Surgery Center
San Juan Capistrano, California, United States, 92675
Sponsors and Collaborators
Klein, Jeffrey A., M.D.
  More Information

No publications provided

Responsible Party: Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier: NCT01046981     History of Changes
Other Study ID Numbers: 2 TAD
Study First Received: January 11, 2010
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Klein, Jeffrey A., M.D.:
Surgical site infections
Prevention
Prophylaxis
Tumescent
Intravenous
Antibiotic
Absorption
Pharmacokinetics
Bioavailability

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Cefazolin
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014