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Irrigation Solution

Irrisept Solution for Spinal Diseases

N/A

Waitlist Available

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed for change at 12 months

Awards & highlights

Study Summary

This trial is testing a new irrigation solution for lumbar spinal fusion surgery to see if it prevents infection and improves outcomes.

Who is the study for?

This trial is for adults aged 18-85 who are having their first lumbar spinal fusion surgery, involving up to three levels of the spine. It's not open to those who've had a previous lumbar fusion (though prior decompression alone is okay), or individuals with spinal infections or tumors.Check my eligibility

What is being tested?

The study is examining the effectiveness of Irrisept irrigation solution during lumbar spinal fusion surgeries. It aims to see how well it works in preventing surgical site infections and improving the rate at which bones fuse together, as well as patient-reported outcomes.See study design

What are the potential side effects?

The description does not specify side effects; however, potential risks may include typical surgical complications such as infection or adverse reactions specific to the use of Irrisept irrigation solution.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 85 years old and having a lumbar spinal fusion surgery of up to 3 levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative surgical site infections

Secondary outcome measures

Fusion rates after surgery

Patient outcome measures

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Irrisept irrigation solutionActive Control1 Intervention

ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects

Group II: normal saline control armPlacebo Group1 Intervention

ii. normal saline used after initial skin incision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Irrimax CorporationIndustry Sponsor

8 Previous Clinical Trials

1,901 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,107 Total Patients Enrolled

Media Library

Irrisept Irrigation solution (Irrigation Solution) Clinical Trial Eligibility Overview. Trial Name: NCT05011942 — N/A

Lumbar Spine Disease Research Study Groups: Irrisept irrigation solution, normal saline control arm

Lumbar Spine Disease Clinical Trial 2023: Irrisept Irrigation solution Highlights & Side Effects. Trial Name: NCT05011942 — N/A

Irrisept Irrigation solution (Irrigation Solution) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011942 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project permit older adults to participate?

"This clinical trial stipulates that the minimum age of admission is 18 years old and the maximum allowable age is 85."

Answered by AI

Am I eligible to join this scientific experiment?

"This medical investigation is seeking 50 participants, aged 18 and over to 85 years old, with a spinal disorder. Furthermore, these patients must be undergoing primary lumbar fusion surgeries of no more than 3 levels in order to qualify for the trial."

Answered by AI

Are there still opportunities to take part in this trial?

"Clinicaltrials.gov reports that this particular trial is not presently enrolling participants, as it was initially posted on September 1st 2021 and last edited nearly a month later. However, there are 37 other medical trials recruiting patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Irrisept Spinal Fusion Pilot Study Protocol

2021. "Irrisept Spinal Fusion Pilot Study Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05011942.