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Tumescent Anesthesia Antibiotic Delivery (TAAD)

NCT03226626 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2021-02-02

No results posted yet for this study

Summary

This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery:

Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food \& Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath

Conditions

Interventions

DRUG

Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD

Concomitant tumescent anesthesia antibiotic delivery (TAAD) \& Intravenous antibiotic delivery (IVAD).

DEVICE

SubQKath

The device intervention consists of using the SubQKath device to provide subcutaneous delivery of antibiotics.

Sponsors & Collaborators

  • University of California, Riverside

    collaborator OTHER

  • HK Surgical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-01-01
Completion
2022-07-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226626 on ClinicalTrials.gov