Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery

Study Overview
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Brief Summary
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To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.

Detailed Description
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Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.

Official Title
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Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery

Conditions
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Lumbar Spine Degeneration, Cervical Spine Degeneration

Intervention / Treatment
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* Drug: saline 0.9%
* Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized preoperatively to the study group (Irrisept) versus the control group (sterile saline irrigation). Standard betadine and/or chloraprep solution will be used to prep the patient. Control group will get normal saline for irrigation throughout the case while study group will be irrigated with the Irrisept solution intermittently throughout the procedure per surgeon discretion. No Vancomycin powder will be used in both groups at the time of closure. Standard closure will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Patients in this group will be given the placebo (sterile saline). | Drug: saline 0.9%<br>* Control group will get normal saline for irrigation throughout the case.<br>* Other names: sterile saline;|
| Active Comparator: Irrisept<br>Patients in this group will be given the study drug (Irrisept). | Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)<br>* Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.<br>* Other names: Irrisept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Disease Control (CDC)-defined 90-day surgical site infection incidence | Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test. | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test | 90 days after surgery | 
| Wound complications | Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test. | 90 days after surgery |