What side effects are associated with this type of intervention?

Common treatments for Lumbar Spine Disease with antimicrobial properties, such as antibiotics, can lead to side effects including gastrointestinal disturbances (nausea, diarrhea), allergic reactions, and potential development of antibiotic resistance. Non-steroidal anti-inflammatory drugs (NSAIDs), often used to manage pain and inflammation, may cause gastrointestinal issues (ulcers, bleeding), cardiovascular risks (heart attack, stroke), and renal impairment. These side effects necessitate careful monitoring and consultation with a healthcare provider.

What prior FDA approvals exist?

FDA approvals for the treatment of Lumbar Spine Disease have included various pharmacologic and non-pharmacologic interventions. While specific antimicrobial irrigation solutions like Irrisept are still under investigation, other treatments such as antibiotics for postoperative infection control and antimicrobial bone graft substitutes have been explored. These treatments aim to reduce infection rates and improve surgical outcomes. Additionally, non-antimicrobial treatments like vertebral augmentation and physical therapy are commonly used to manage symptoms and improve quality of life in patients with lumbar spine disease.

What other types of research exist?

Promising alternatives to Irrisept Irrigation Solution for lumbar spine disease patients include: 1) Daptomycin, which has shown efficacy in pediatric patients with staphylococcal bacteremia and osteomyelitis, indicating strong antimicrobial properties. 2) Linezolid, which has been effective in treating methicillin-resistant Staphylococcus aureus (MRSA) infections in children, suggesting potential use in spinal surgeries. 3) Quinupristin/dalfopristin, which has demonstrated safety and efficacy in treating invasive Gram-positive infections in pediatric patients. These alternatives offer strong antimicrobial properties that could help reduce postoperative infections in lumbar spine surgeries.

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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

Must not have

History of spinal infection

History of prior lumbar fusion (decompression only okay)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed for change at 12 months

Awards & highlights

Summary

This trial is testing Irrisept, a cleaning solution, on patients having lower back surgery to see if it helps prevent infections and affects healing. The study will help decide if this solution should be used more widely in these surgeries.

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a spinal infection in the past.

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I have had surgery to fuse bones in my lower back.

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I have had a tumor in my spine.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative surgical site infections

Secondary study objectives

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lumbar Spine Disease include both nonpharmacologic and pharmacologic approaches. Nonpharmacologic treatments such as exercise, physical therapy, and mind-body interventions (e.g., yoga, Tai-chi) aim to improve function and reduce pain through movement and psychological support. Pharmacologic treatments, including NSAIDs and muscle relaxants, provide symptomatic relief to facilitate participation in active therapies. The Irrisept Irrigation Solution, with its antimicrobial properties, specifically targets infection control during surgical interventions, which is crucial for preventing postoperative complications and promoting healing. This is particularly important for Lumbar Spine Disease patients as infections can significantly impact recovery and overall outcomes.

[Neuro-reflexotherapy intervention in the treatment of non specified low back pain: a randomized, controlled, double-blind clinical trial].Randomized controlled trials reflected clinical practice when comparing the course of low back pain symptoms in similar populations.Neurological Outcomes After Surgical or Conservative Management of Spontaneous Spinal Epidural Abscesses: A Systematic Review and Meta-Analysis of Data From 1980 Through 2016.

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Who is running the clinical trial?

Irrimax CorporationIndustry Sponsor

9 Previous Clinical Trials

2,027 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

488 Previous Clinical Trials

172,405 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

~12 spots leftby Sep 2025

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