Last updated on December 2016

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

Brief description of study

This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept device and half of the subjects will receive the respective institution's Standard of Care (SoC).

Detailed Study Description

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.

Clinical Study Identifier: NCT02255487

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Baystate Medical Center

Springfield, MA United States
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