Tumescent Anesthesia Antibiotic Delivery (TAAD)

NCT03226626 | Unknown Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: TAAD
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

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

Conditions

Surgical Site Infection; Thrombosis; Sepsis

Keywords

Tumescent; Lidocaine; Epinephrine; Cefazolin; Metronidazole; Surgical Site Infection; Thrombosis; Sepsis; Prevention; Prophylaxis

Outcome Measures

Primary Outcomes (4)

• surgical site infection (SSI)

  Occurrence of a surgical site infection (SSI)

  within 30 of surgical procedure

• Post-operative venous thromboembolism

  Diagnosis of Post-operative venous thromboembolism

  within 30 of surgical procedure

• Sepsis

  Diagnosis of Post-operative sepsis

  within 30 of surgical procedure

• Adverse event associated with SubQKath device

  any adverse event

  within 30 of surgical procedure

Secondary Outcomes (5)

• Length of Stay (LOS) in hospital after surgery (hours)

  60 days

• Time in post-operative/post-anesthesia recovery unit.

  30 days post-op

• Post-Op Narcotic Requirements (total mg and mg/kg)

  30 days post op

• General Anesthesia Requirements (Quantitative Measure)

  day of surgery

• Diagnosis of C. Difficile colitis

  30 Days Postop

Study Arms (2)

IVAD

ACTIVE COMPARATOR

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

TAAD + IVAD

EXPERIMENTAL

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; Device: SubQKath

Interventions

Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD DRUG

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

Also known as: SubQKath

IVAD; TAAD + IVAD

SubQKath DEVICE

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

TAAD + IVAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Pre-existing skin infection Pregnant Less than 18 years old

Sponsors & Collaborators

• HK Surgical, Inc.: lead
• University of California, Riverside: collaborator

Related Publications (2)

• Klein JA, Jeske DR. Estimated Maximal Safe Dosages of Tumescent Lidocaine. Anesth Analg. 2016 May;122(5):1350-9. doi: 10.1213/ANE.0000000000001119.

  PMID: 26895001 BACKGROUND

• Klein JA, Langman LJ. Prevention of Surgical Site Infections and Biofilms: Pharmacokinetics of Subcutaneous Cefazolin and Metronidazole in a Tumescent Lidocaine Solution. Plast Reconstr Surg Glob Open. 2017 May 30;5(5):e1351. doi: 10.1097/GOX.0000000000001351. eCollection 2017 May.

  PMID: 28607871 BACKGROUND

Related Links

• Information about subcutaneous tumescent drug delivery

MeSH Terms

Conditions

Surgical Wound Infection; Thrombosis; Sepsis

Interventions

1,3,4,6-tetra-O-acetyl-2-azido-2-deoxyglucopyranose

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Meta-Analysis Multicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: December 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: July 31, 2022
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share