Venous Thromboembolism Clinical Trial
Official title:
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial
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).
Tumescent antibiotic delivery (TAD) is defined as 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.
The investigators hypothesize that TAD with intravenous antibiotic delivery (IVAD) will
significantly reduce the incidence of SSI.
The Principal aim of the present research is to compare two methods of antibiotic delivery:
concomitant TAD and IVAD versus IVAD alone (TAD+IVAD vs IVAD) with respect to the prevention
of surgical site infections (SSI). The secondary aim of this study is to compare TAD+IVAD vs
IVAD with respect to the prevention of post-operative venous thromboembolism (VTE). This
research is an open label randomized clinical trial (RCT) comparing two modes of antibiotic
delivery. It is not a trial comparing antibiotics.
The target populations for the present clinical trial are patients who have a high risk of
SSI. These include patients exposed to high-risk surgical procedures (open abdominal
surgeries, trauma surgeries, burn surgeries, sternotomy) or are obese, have diabetes, are
immune-compromised or are otherwise at increased risk of SSI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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