Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery (Irrisept)

December 23, 2022 updated by: Don Moore, MD, University of Missouri-Columbia
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.

Study Type

Interventional

Phase

  • 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 Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Missouri Orthopaedic Institute

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a need for isolated open posterior spine procedures using a posterior open approach.
  • Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
  • >18 years old and able to provide informed consent

Exclusion Criteria:

  • Ongoing or suspected infection
  • Revisions of failed back surgeries
  • Documented allergy to CHG or CHG products
  • Pregnancy - qualitative beta human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
  • Prisoners or wards of the state
  • Unable to consent to research study

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Patients in this group will be given the placebo (sterile saline).
Drug: saline 0.9%
Control group will get normal saline for irrigation throughout the case.
Other Names:
  • sterile saline
Active Comparator: Irrisept
Patients in this group will be given the study drug (Irrisept).
Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)
Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.
Other Names:
  • Irrisept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Disease Control (CDC)-defined 90-day surgical site infection incidence
Time Frame: 90 days after surgery
Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test.
90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 90 days after surgery
Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test
90 days after surgery
Wound complications
Time Frame: 90 days after surgery
Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test.
90 days after surgery

Collaborators and Investigators

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

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Don Kim Moore, MD, University of Missouri - Missouri Orthopaedic Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Estimate)

December 26, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2083162

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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