IrrSept vs. Standard of Care in Prevention of Surgical Site Infections

IRR-CT-901-2013-01 is a Phase IV, multi-center, prospective, randomized, controlled,
comparator clinical trial. The study consists of 3 parts: a Screening Phase typically
performed in the Emergency Department, a randomized, open-label Treatment (Perioperative)
Phase, and End of Study, a 30-day Follow-up.

Medical Centers throughout the United States will participate as research sites, enrolling
eligible subjects 18 years of age and older who undergo open abdominal laparotomy for
abdominal trauma or acute surgical abdomen. Subjects will be randomized in a 1 - 1 ratio to
receive the IrriSept irrigation device or the institution's Standard of Care (SoC) prior to
abdominal surgery.

Exclusion criteria includes: known allergy to chlorhexidine gluconate (CHG), Abbreviated
Injury Scale (AIS) score of six (6), American Society of Anesthesiologists Physical Status
Classification (ASA) score of five (5) or greater, female subjects who are pregnant and/or
breast feeding, those patients undergoing a damage control laparotomy, abdominal incision
created prior to operating room, and patients enrolled in a concurrent, ongoing
interventional, randomized clinical trial.

Patient risk factors assessed at screening include chronic uncontrolled hypertension,
chronic heart disease, chronic renal disease, chronic pulmonary disease, diabetes mellitus,
HIV, chronic liver disease, a BMI of less than 18 or above 40, coagulopathy, current
long-term steroid use, current smoker, and current cancer. Additional assessments include
PATI (Penetrating Abdominal Trauma Index), AIS and ASA scores, and adherence to SCIP
prophylactic antibiotic-specific guidelines. Other measures to be documented will include
antibiotic usage and surgical skin preparation. The following "present on admission" (PoA)
characteristics will be collected: shock, (systolic BP < 90 mm Hg), intubation, active
infection, transfusion of blood/blood products and primary injury in trauma or primary
organ(s) in the acute abdomen. Intra-operative SSI risk factors including drains, staple
versus sutures, surgical time (skin to skin), blood/blood products, and body temperature
below 36 degrees Celsius will also be evaluated and risk adjusted in the final analysis.

Exploratory endpoints at study completion include: infection (superficial, deep, organ
space), ventilator associated pneumonia (VAP), catheter associated urinary tract infection
(CAUTI), central line associated blood stream infection (CLABSI), deep vein thrombosis
(DVT), pulmonary embolus (PE), acute cardiac event, Clostridium difficile (C-diff)
infection, MRSA infection, mortality and length of stay (LOS).

The Standard of Care (SoC) arm subjects will receive routine surgical Standard of Care
(SoC). It should be noted that routine SoC is at the sole discretion of the investigator and
institution and may or may not involve surgical wound irrigation. If irrigation is used, it
will be delivered by bulb syringe or pour method but not a pressure device, which can range
from a syringe with a cannula to jet lavage.

While the primary objective of this research involves surgical site infections, hospital
readmission rates, hospital costs, and length of hospital stay will also be compared between
the two study arms as secondary objectives.

Inclusion Criteria:

1. Is male or female, 18 years of age or older

2. Has provided written informed consent or has surrogate consent provide by a Legally
Authorized Representative (LAR)

3. Has experienced abdominal trauma, blunt or penetrating requiring open abdominal
laparotomy with primary closure -or-

4. Has experienced acute surgical abdomen requiring open abdominal laparotomy with
primary closure

Exclusion Criteria:

1. Known allergy to Chlorhexidine Gluconate (CHG)

2. Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for
all trauma patients

3. American Society of Anesthesiologists Physical Status Classification (ASA) score of
five (5) or greater (As ASA scoring is a subjective measure, if the PI finds the
patient stable enough for study participation despite a score of 5, enrollment may
continue)

4. Female volunteers who are pregnant and/or breast feeding

5. Damage control laparotomy

6. Abdominal incision created prior to operating room

7. Currently enrolled in an ongoing, interventional, randomized clinical trial