Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
Withdrawn before enrolling · Phase 4 · Has a placebo group
Conditions studied: Lumbar Spine Degeneration, Cervical Spine Degeneration
In brief
To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.
Key facts
- Study ID
- NCT05408923
- Run by
- University of Missouri-Columbia
- People needed
- 0
- Starts
- 2022-07-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2022-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Missouri Orthopaedic Institute — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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