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

A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the IrriSept System Versus Standard of Care on the Prevalence of Surgical Site Infection in Patients With Abdominal Trauma or Acute Surgical Abdomen

Sponsors

Lead Sponsor: Irrimax Corporation

Source Irrimax Corporation
Brief Summary

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 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.

Overall Status Completed
Start Date August 2014
Completion Date July 2017
Primary Completion Date June 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of surgical site infections (SSI) 30 days post surgical procedure
Secondary Outcome
Measure Time Frame
Hospital readmission rates 30 days post surgical procedure
Hospital costs 30 days post surgical procedure
Length of hospital stay 30 days post surgical procedure
Enrollment 625
Condition
Intervention

Intervention Type: Device

Intervention Name: IrriSept System

Description: The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation. Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation.

Arm Group Label: IrriSept System

Intervention Type: Other

Intervention Name: No Intervention - Standard of Care (SoC) only

Description: Institution will provide routine Standard of Care (SoC) only surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Arm Group Label: Standard of Care (SoC) only

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Donald Fry, MD Study Director Michael Pine Associates
Location
Facility:
University of Arizona/Banner Health Medical Center | Tucson, Arizona, 85724, United States
LA County/USC Medical Center | Los Angeles, California, 90033, United States
Denver Health | Denver, Colorado, 80204, United States
Tampa General Hospital | Tampa, Florida, 33606, United States
University of Iowa Hospitals | Iowa City, Iowa, 52242, United States
University of Kentucky | Lexington, Kentucky, 40536, United States
University of Maryland Medical Center | Baltimore, Maryland, 21201, United States
Baystate Medical Center | Springfield, Massachusetts, 01199, United States
University of Michigan | Ann Arbor, Michigan, 48109, United States
Saint Louis University | Saint Louis, Missouri, 63110, United States
University of Cincinnati | Cincinnati, Ohio, 45267, United States
MetroHealth | Cleveland, Ohio, 73160, United States
Wright State/Miami Valley Hospital | Dayton, Ohio, 45409, United States
Elvis Presley Trauma Center | Memphis, Tennessee, 38163, United States
University of Texas SW-Parkland Hospital | Dallas, Texas, 75390, United States
Memorial Hermann Hospital | Houston, Texas, 77030, United States
University of TX Health Science Center San Antonio | San Antonio, Texas, 78229, United States
University of Washington Harborview Medical Center | Seattle, Washington, 98104, United States
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States
Location Countries

United States

Verification Date

July 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: IrriSept System

Type: Experimental

Description: IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen

Label: Standard of Care (SoC) only

Type: Active Comparator

Description: Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

Source: ClinicalTrials.gov