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Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection

NCT02503904 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-07-21

No results posted yet for this study

Summary

The principal aim of the present research is to compare two methods of antibiotic delivery: concomitant tumescent antibiotic delivery (TAD) and intravenous antibiotic delivery (IVAD) versus IVAD alone, (TAD+IVAD vs IVAD), with respect to the prevention of surgical site infections (SSI). The investigators hypothesize that TAD+IVAD will significantly reduce the incidence of SSI compared to IVAD.

TAD is the subcutaneous infiltration of a dilute solution of antibiotic(s) in a solution of tumescent local anesthesia (TLA). TLA consists of a dilute solution of lidocaine (1gm/L), epinephrine (1mg/L) and sodium bicarbonate (10mEq/L) in 0.9% physiologic saline.

A secondary aim of this study is to compare TAD+IVAD vs IVAD with respect to the prevention of post-operative venous thromboembolism (VTE).

Conditions

  • Surgical Site Infections
  • Venous Thromboembolism

Interventions

PROCEDURE

Concomitant Tumescent Antibiotic Delivery & IV Delivery

Concomitant subcutaneous infiltration of a dilute antibiotics (cefazolin and metronidazole) in a dilute solution of tumescent lidocaine and epinephrine at the site of a proposed surgical incision.

DEVICE

Subcutaneous Tumescent Infiltration

Subcutaneous tumescent infiltration using HK tumescent infiltration cannulas and HK tumescent infiltration pump

DRUG

cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline)

Sponsors & Collaborators

  • Klein, Jeffrey A., M.D.

    lead INDIV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-06-30
Completion
2019-12-31

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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 NCT02503904 on ClinicalTrials.gov