Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection
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.
Inclusion Criteria:

 -  1. Subjects greater than 18 years of age scheduled for surgical procedure 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 must 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.

 3. Only adults will participate as research subjects 4. This study will involve both
 males and females 5. Patients in ASA (American Society of Anesthesiology) class I or
 II or III or IV will be included. Treatment assignment will be stratified with respect
 to ASA classification.

 6. Abdominal wound classifications: Clean-Contaminated, Contaminated, or Dirty are
 eligible to participate. Treatment assignment will be stratified with respect wound
 classification. Similarly, trauma and burn patients will be classified.

 7. Patient must be able to understand the same written and spoken language as either
 the surgeon or nurse who provides informed-consent information to the patient.

 8. Patients must be appropriately screened for the proposed surgery.

 Exclusion Criteria:

 Procedures involving only simple ostomy closures 2. Known allergy to cefazolin or
 metronidazole or an antibiotic preferred and routinely used by the surgeon 3. Persons less
 than 18 years old 4. Emergency operation as designated by the surgeon will be included only
 with the appropriate approval by the institutional IRB at an individual research site 5.
 Pregnant or breast-feeding women 6. A known bleeding/hemorrhagic/thrombotic disorder is
 exclusionary unless there is a written clearance chart-note or clearance letter from a
 primary care physician or hematologist 7. Significant psychiatric problems which might
 impair ability to give truly informed consent or which may impair follow-up communication
 with the surgeon and staff 8. Clinically significant cardiac arrhythmias are exclusionary
 unless there is a written clearance chart-note or clearance letter from a cardiologist 9.
 Heart/liver/kidney disease, neuropsychiatric disease classifying patient as ≥ ASA V 10.
 Major concomitant infections such as pneumonia or sepsis 11. In non-emergency surgery,
 pre-existing active bacterial skin infection at the time of the surgical incision; however,
 pre-existing bacterial infections are not exclusionary in burn or trauma patients.

 12. Foreign material in the incision that cannot be removed 13. Recent systemic
 antimicrobial therapy 14. Clinically significant renal impairment or a creatinine clearance
 < 30 mL/min.

 Vulnerable Subjects are excluded

 1. Pregnant women

 2. Nursing home residents, or other institutionalized persons are not fully alert, not
 cognizant or and not able to give informed consent are not eligible to participate as
 a research subject

 3. Children < 18 years of age