Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention

March 28, 2024 updated by: Brett D. Crist

Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures

Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult, 18 or over
  2. Gustilo-Anderson type III open tibia fracture
  3. Able to obtain informed consent from patient

Exclusion Criteria:

  1. Minor, under 18
  2. Pregnancy
  3. Prisoner
  4. Allergic to chlorhexidine gluconate
  5. Allergic to vancomycin or tobramycin
  6. Patient's tibia is unable to accommodate the smallest antibiotic nail
  7. Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard operative debridement and spanning external fixator (reference/control group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Drug: Saline
Saline irrigation
Experimental: Spanning external fixator with Irrisept irrigation (treatment group 1)
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Drug: Irrisept (Irrigation Solution)
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
Experimental: Antibiotic-coated medullary nail with saline irrigation (treatment group 2)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Drug: Saline
Saline irrigation
Experimental: Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Drug: Irrisept (Irrigation Solution)
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Surgical Site Infection (SSI)
Time Frame: 90 days
Measured by the number of surgical site infections in the total population of patients.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Fracture Healing
Time Frame: 6 months
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brett D. Crist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2086908

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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