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NCT01046981 · ClinicalTrials.gov registry record · Phase 1
Tumescent Antibiotic Delivery Pharmacokinetics
A Phase 1 study of Prevention of Surgical Site Infections, sponsored by Klein, Jeffrey A., M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT01046981: Completed Phase 1 study of Prevention of Surgical Site Infections, sponsored by Klein, Jeffrey A., M.D..
NCT01046981 is a Phase 1 study of Prevention of Surgical Site Infections that has completed, run by Klein, Jeffrey A., M.D.. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01046981, a Phase 1 study of Prevention of Surgical Site Infections, has completed, sponsored by Klein, Jeffrey A., M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Tumescent Antibiotic Delivery of cefazolin with or without metronidazole
- PROCEDURE Intravenous Antibiotic Delivery
Study Locations (1)
California
- Capistrano Surgery Center - San Juan Capistrano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01046981 record still lists
NCT01046981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Prevention of Surgical Site Infections appearing as the primary indexed condition, and to 2 interventions - of which Tumescent Antibiotic Delivery of cefazolin with or without metronidazole is the first listed.
NCT01046981 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01046981 about?
NCT01046981 is a clinical study titled "Tumescent Antibiotic Delivery Pharmacokinetics". 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 subcutaneo...
What is the current status of trial NCT01046981?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2009-03. Estimated completion is 2011-08.
What conditions does trial NCT01046981 study?
This clinical trial studies the following conditions: Prevention of Surgical Site Infections.
What interventions are being tested in trial NCT01046981?
The interventions under investigation include: Tumescent Antibiotic Delivery of cefazolin with or without metronidazole (PROCEDURE), Intravenous Antibiotic Delivery (PROCEDURE).
Who is sponsoring clinical trial NCT01046981?
This trial is sponsored by Klein, Jeffrey A., M.D., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01046981 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01046981's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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