Surgical Site InfectionNCT02255487
Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
A study testing IrriSept System in people with Surgical Site Infection, run by Irrimax Corporation at 17 sites in United States.
Trial summary
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- IrriSept System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- 17 sitesUnited States
- Study dates
- 18 Feb 2015to 13 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female, 18 years of age or older
- Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
- Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
- Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure
Who cannot join
- Known allergy to Chlorhexidine Gluconate (CHG)
- Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
- 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.)
- Female volunteers who are pregnant and/or breast feeding
- Damage control laparotomy
- Abdominal incision created prior to operating room (i.e. incision made in trauma bay to cross clamp the aorta)
- Currently enrolled in an ongoing, interventional, randomized clinical trial
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The University of Maryland, Baltimore
Baltimore, Maryland, 21201
The University of Cincinnati Health
Cincinnati, Ohio, 45267
The MetroHealth System
Cleveland, Ohio, 73160
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Denver Health and Hospital Authority
Denver, Colorado, 80204
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
The University of Iowa
Iowa City, Iowa, 52242
The University of Kentucky Research Foundation
Lexington, Kentucky, 40536
The University of Southern California, USC Medical Center
Los Angeles, California, 90033
Regional One Health Research Institute
Memphis, Tennessee, 38163
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
The University of Washington, Harborview Medical Center
Seattle, Washington, 98104
Baystate Medical Center
Springfield, Massachusetts, 01199
Saint Louis University
St Louis, Missouri, 63110
The University of South Florida, Tampa General Hospital
Tampa, Florida, 33606
The University of Arizona
Tucson, Arizona, 85724
About this study
Official title: A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
Read the detailed description
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.
- Conditions
- Surgical Site Infection
- Being tested
- IrriSept System, No Intervention - Standard of Care (SoC) only
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrriSept SystemDevice
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) onlyOther
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
| Study group | Role | What they receive |
|---|---|---|
| IrriSept System | Experimental | IrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen Receives: Device: IrriSept System |
| Standard of Care (SoC) only | Active comparator | Institution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen. Receives: Other: No Intervention - Standard of Care (SoC) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With Surgical Site Infections (SSI)
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
Measured: 30 (+/- 3) days post-surgical procedure
Secondary outcomes (3)
Hospital Readmission Rates
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Measured: 30 (+/- 3) days post-surgical procedure
Hospital Costs
A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.
Measured: 0 days
Length of Hospital Stay
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
Measured: 30 (+/- 3) days post-surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start18 Feb 2015
- Primary completion13 Mar 2017
- Study completion13 Mar 2017
Why it stopped: The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization methodology was controlled by the site.
- Masking
- None (open label)
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irrimax Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Fry, MD, Study director, Michael Pine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255487
- Sponsor's protocol ID
- IRR-CT-901-2013-01
- Status last verified
- Apr 2022
- First submitted
- 30 Sep 2014
- Last updated
- 24 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the Irrisept System Versus Standard of Care (SoC) on the Prevalence of Surgical Site Infections in Patients With Abdominal Trauma or Acute Surgical Abdomen
- ClinicalTrials.gov ID
- NCT02255487
- Acronym / sponsor ID
- IRR-CT-901-2013-01
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Irrimax CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 13 Mar 2017 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 24 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
Detailed description
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization methodology was controlled by the site.
| Arm | Type | Receives |
|---|---|---|
| IrriSept System | Experimental | Device: IrriSept SystemIrriSept device used for surgical irrigation in subjects with abdominal trauma or acute surgical abdomen |
| Standard of Care (SoC) only | Active comparator | Other: No Intervention - Standard of Care (SoC) onlyInstitution will provide routine Standard of Care (SoC) surgical preparation for subjects with abdominal trauma or acute surgical abdomen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is male or female, 18 years of age or older
- Has provided written informed consent or has surrogate consent provided by a Legally Authorized Representative (LAR)
- Has experienced abdominal trauma, blunt or penetrating, requiring open abdominal laparotomy with primary closure or
- Has experienced acute surgical abdomen requiring open abdominal laparotomy with primary closure
Key exclusion criteria (7 listed)
- Known allergy to Chlorhexidine Gluconate (CHG)
- Estimated Abbreviated Injury Scale (AIS) score of six (6) at the time of surgery, for all trauma patients
- 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.)
- Female volunteers who are pregnant and/or breast feeding
- Damage control laparotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrriSept SystemThe 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. | Device | IrriSept System |
| No Intervention - Standard of Care (SoC) onlyInstitution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen. | Other | Standard of Care (SoC) only |
Primary outcome
Percent of Subjects With Surgical Site Infections (SSI)
Time frame: 30 (+/- 3) days post-surgical procedure
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
3 secondary outcomes
Hospital Readmission Rates
Time frame: 30 (+/- 3) days post-surgical procedure
Hospital Costs
Time frame: 0 days
Length of Hospital Stay
Time frame: 30 (+/- 3) days post-surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Fry, MD study director
Michael Pine Associates
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IrriSept System in people with Surgical Site Infection, run by Irrimax Corporation at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Subjects With Surgical Site Infections (SSI) (time frame: 30 (+/- 3) days post-surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.