Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255487
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Infection Device: IrriSept System Other: No Intervention - Standard of Care (SoC) only Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 625 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IrriSept System
IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
Device: IrriSept System

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.


Active Comparator: Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Other: No Intervention - Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) only surgical preparation for subjects with abdominal trauma or acute surgical abdomen.




Primary Outcome Measures :
  1. Rate of surgical site infections (SSI) [ Time Frame: 30 days post surgical procedure ]
    Compare the rate of SSI in the IrriSept system randomization group to the rate of SSI in Standard of Care randomization group.


Secondary Outcome Measures :
  1. Hospital readmission rates [ Time Frame: 30 days post surgical procedure ]
    Compare the hospital readmission rate of subjects receiving the IrriSept system to the hospital readmission rate of subjects receiving Standard of Care treatment.

  2. Hospital costs [ Time Frame: 30 days post surgical procedure ]
    Compare the estimated hospital cost to charge ratio between the IrriSept system and Standard of Care.

  3. Length of hospital stay [ Time Frame: 30 days post surgical procedure ]
    Compare the length of hospital stay between IrriSept system and Standard of Care.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255487


Locations
Show Show 19 study locations
Sponsors and Collaborators
Irrimax Corporation
Investigators
Layout table for investigator information
Study Director: Donald Fry, MD Michael Pine Associates
Layout table for additonal information
Responsible Party: Irrimax Corporation
ClinicalTrials.gov Identifier: NCT02255487    
Other Study ID Numbers: IRR-CT-901-2013-01
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Irrimax Corporation:
surgical device
surgical irrigation device
surgical site infection prophylaxis
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes