Irrisept for Preventing Infection After Spinal Fusion

This study is testing if using Irrisept irrigation solution during lumbar spinal fusion surgery can help prevent infections. Lumbar spinal fusion is a surgery on your lower back. Researchers will compare Irrisept to a normal saline solution. You might be able to join if you are between 18 and 85 years old and are having your first lumbar spinal fusion surgery (up to 3 levels). You cannot join if you've had a previous lumbar fusion, a spinal infection, or spinal cancer. The main goal is to see if Irrisept reduces surgical site infections at 1, 3, and 6 months after surgery. The current status of this study is unclear, and it plans to enroll 50 patients.

Study design
This is a randomized controlled pilot study, meaning participants are randomly assigned to receive either Irrisept or normal saline. It plans to include 50 patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for changes in postoperative surgical site infections at 1, 3, and 6 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05011942

Irrisept Spinal Fusion Pilot Study Protocol

Enrolling by Invitation
NAAges 18–85InterventionalPrevention
University of Kansas Medical Center
~50 participants
Updated 2024-09-19 on ClinicalTrials.gov
What's tested:Irrisept Irrigation solution

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Postoperative surgical site infections
Measured over assessed for change at 1 month
+3 more outcomes measured
Lumbar Spine Disease
1 sites across 1 states
Kansas1

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)

Exclusion

Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm
  • Postoperative surgical site infectionsassessed for change at 1 month

    Postop SSI

  • Postoperative surgical site infectionsassessed for change at 3 months

    postop SSI

  • Postoperative surgical site infectionsassessed for change at 6 months

    postop SSI

  • Postoperative surgical site infectionsassessed for change at 12 months

    postop SSI