Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
NCT ID: NCT02255487
Last Updated: 2022-05-24
Study Results
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View full resultsBasic Information
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TERMINATED
NA
627 participants
INTERVENTIONAL
2015-02-18
2017-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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IrriSept System
IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen
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.
Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
No Intervention - Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Interventions
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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.
No Intervention - Standard of Care (SoC) only
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
Eligibility Criteria
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Inclusion Criteria
2. Has provided written informed consent or has surrogate consent provided 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
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 (i.e. incision made in trauma bay to cross clamp the aorta)
7. Currently enrolled in an ongoing, interventional, randomized clinical trial
18 Years
ALL
No
Sponsors
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Irrimax Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Fry, MD
Role: STUDY_DIRECTOR
Michael Pine Associates
Locations
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The University of Arizona
Tucson, Arizona, United States
The University of Southern California, USC Medical Center
Los Angeles, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
The University of South Florida, Tampa General Hospital
Tampa, Florida, United States
The University of Iowa
Iowa City, Iowa, United States
The University of Kentucky Research Foundation
Lexington, Kentucky, United States
The University of Maryland, Baltimore
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Saint Louis University
St Louis, Missouri, United States
The University of Cincinnati Health
Cincinnati, Ohio, United States
The MetroHealth System
Cleveland, Ohio, United States
Regional One Health Research Institute
Memphis, Tennessee, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
The University of Washington, Harborview Medical Center
Seattle, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRR-CT-901-2013-01
Identifier Type: -
Identifier Source: org_study_id
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