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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
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 belowSelect...
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:Select...
I have had a spinal infection in the past.
Select...
I have had surgery to fuse bones in my lower back.
Select...
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
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.
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.
[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
496 Previous Clinical Trials
173,947 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a spinal infection in the past.I have had surgery to fuse bones in my lower back.I have had a tumor in my spine.I am between 18 and 85 years old and having a lumbar spinal fusion surgery of up to 3 levels.
Research Study Groups:
This trial has the following groups:- Group 1: Irrisept irrigation solution
- Group 2: normal saline control arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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