Status:
WITHDRAWN
Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
Lead Sponsor:
University of Missouri-Columbia
Conditions:
Lumbar Spine Degeneration
Cervical Spine Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.
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 infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05408923
Start Date
July 1 2022
End Date
July 1 2026
Last Update
December 27 2022
Active Locations (1)
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1
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65211