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Tumescent Antibiotic Delivery Pharmacokinetics

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ClinicalTrials.gov Identifier: NCT01046981
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
Klein, Jeffrey A., M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Prevention of Surgical Site Infections Procedure: Tumescent Antibiotic Delivery of cefazolin with or without metronidazole Procedure: Intravenous Antibiotic Delivery Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Area Under the Curve (AUC) of antibiotic concentration as a function of time [ Time Frame: 24 hours ]


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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

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.

Additional Information:
Responsible Party: Klein, Jeffrey A., M.D.
ClinicalTrials.gov Identifier: NCT01046981     History of Changes
Other Study ID Numbers: 2 TAD
First Posted: January 12, 2010    Key Record Dates
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