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Tumescent Anesthesia Antibiotic Delivery (TAAD) (TAAD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226626
Recruitment Status : Not yet recruiting
First Posted : July 24, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
University of California, Riverside
Information provided by (Responsible Party):
HK Surgical, Inc.

Brief 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


Condition or disease Intervention/treatment Phase
Surgical Site Infection Thrombosis Sepsis Drug: Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD Device: SubQKath Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Meta-Analysis Multicenter Randomized Clinical Trial
Masking: Single (Outcomes Assessor)
Masking Description: Persons making decision to categorize the outcome as either "Infection Occurred" or "No Infection Occurred" will be masked with respect to whether or not the subject received Standard pre-operative IV antibiotics alone or received both IV antibiotics and tumescent anesthesia & antibiotic delivery (TAAD).
Primary Purpose: Prevention
Official Title: Tumescent Anesthesia Antibiotic Delivery (TAAD) and SubQKath for Prevention of Surgical Site Infection, Thrombosis and Sepsis
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IVAD
IV antibiotic delivery (IVAD) alone as surgical site infection prevention. The intervention is IV antibiotics alone.
Drug: Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD
Concomitant tumescent anesthesia antibiotic delivery (TAAD) & Intravenous antibiotic delivery (IVAD).
Other Name: SubQKath

Experimental: TAAD + IVAD
Both subcutaneous tumescent anesthesia & antibiotic delivery (TAAD) and IVADThe The intervention is subcutanious and IV antibiotics
Drug: Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD
Concomitant tumescent anesthesia antibiotic delivery (TAAD) & Intravenous antibiotic delivery (IVAD).
Other Name: SubQKath

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




Primary Outcome Measures :
  1. surgical site infection (SSI) [ Time Frame: within 30 of surgical procedure ]
    Occurrence of a surgical site infection (SSI)

  2. Post-operative venous thromboembolism [ Time Frame: within 30 of surgical procedure ]
    Diagnosis of Post-operative venous thromboembolism

  3. Sepsis [ Time Frame: within 30 of surgical procedure ]
    Diagnosis of Post-operative sepsis

  4. Adverse event associated with SubQKath device [ Time Frame: within 30 of surgical procedure ]
    any adverse event


Secondary Outcome Measures :
  1. Length of Stay (LOS) in hospital after surgery (hours) [ Time Frame: 60 days ]
    Length of Stay (LOS) in hospital after surgery (hours)

  2. Time in post-operative/post-anesthesia recovery unit. [ Time Frame: 30 days post-op ]
    Time in post-operative/post-anesthesia recovery unit.

  3. Post-Op Narcotic Requirements (total mg and mg/kg) [ Time Frame: 30 days post op ]
    Post-Op Narcotic Requirements (total mg and mg/kg) will be recorded.

  4. General Anesthesia Requirements (Quantitative Measure) [ Time Frame: day of surgery ]
    Quantitative measures of General Anesthesia Requirements (Quantitative Measure)

  5. Diagnosis of C. Difficile colitis [ Time Frame: 30 Days Postop ]
    Antibiotic related diarrhea



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects greater than 18 years of age scheduled for surgical procedures considered to have a high risk for a surgical site infection (SSI) such as 1) secondary repair of a ventral hernia, 2) open bariatric surgery, 3) open abdominal colorectal surgery, 4) trauma surgery, 5) burn surgery or 6) sternotomy.
  2. Patients ought to have one of the following risk factors for surgical site infection: emergency surgery, obesity, diabetes mellitus, cancer surgery, be immune-compromised or otherwise be at an increased risk for SSI, or be in a medically indigent environment where surgical aseptic technique is suboptimal

Exclusion Criteria:

Pre-existing skin infection Pregnant Less than 18 years old

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Additional Information:
Publications:
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Responsible Party: HK Surgical, Inc.
ClinicalTrials.gov Identifier: NCT03226626    
Other Study ID Numbers: TAAD
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by HK Surgical, Inc.:
Tumescent
Lidocaine
Epinephrine
Cefazolin
Metronidazole
Surgical Site Infection
Thrombosis
Sepsis
Prevention
Prophylaxis
Additional relevant MeSH terms:
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Infection
Sepsis
Surgical Wound Infection
Thrombosis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Wound Infection
Postoperative Complications
Anti-Bacterial Agents
Anti-Infective Agents