NCT02503904

Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection

Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection: A Multicenter Open Label Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Klein, Jeffrey A., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Surgical Site Infections
• Venous Thromboembolism

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2015-07-21
• Last updated: 2015-07-21