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Tumescent Antibiotic Delivery Pharmacokinetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046981
First Posted: January 12, 2010
Last Update Posted: September 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klein, Jeffrey A., M.D.
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier: NCT01046981     History of Changes
Other Study ID Numbers: 2 TAD
First Submitted: January 11, 2010
First Posted: January 12, 2010
Last Update Posted: September 28, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Infection
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Metronidazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents