Tumescent Antibiotic Delivery Pharmacokinetics
Tumescent Antibiotic Delivery: Pharmacokinetic Evidence for Improved Surgical Site Infection Prevention
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2009
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 11, 2010
CompletedFirst Posted
Study publicly available on registry
January 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedSeptember 28, 2011
September 1, 2011
2.1 years
January 11, 2010
September 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve (AUC) of antibiotic concentration as a function of time
24 hours
Study Arms (2)
Tumescent Antibiotic Delivery
EXPERIMENTALTAD followed by sequential serum and interstitial tissue fluid sampling for antibiotic concentration of subsequent 24 hours
Intravenous Antibiotic Delivery
EXPERIMENTALIntravenous antibiotic delivery of cefazolin with or without metronidazole followed by sequential serum and interstitial tissue fluid sampling for antibiotic concentration of subsequent 24 hours.
Interventions
TAD of cefazolin with or without metronidazole followed by sequential serum and interstitial fluid samples over 14 to 24 hours for antibiotic concentrations
Intravenous antibiotic delivery of cefazolin with or without metronidazole followed by sequential serum sampling for antibiotic concentration of subsequent 12 to 24 hours.
Eligibility Criteria
You may qualify if:
- Healthy adult
- No allergies to cefazolin, metronidazole or lidocaine
You may not qualify if:
- HIV
- Hepatitis C
- Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capistrano Surgery Center
San Juan Capistrano, California, 92675, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2010
First Posted
January 12, 2010
Study Start
March 1, 2009
Primary Completion
April 1, 2011
Study Completion
August 1, 2011
Last Updated
September 28, 2011
Record last verified: 2011-09