Irrisept Spinal Fusion Pilot Study Protocol

Study Overview
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Brief Summary
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Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.

Detailed Description
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This is a randomized controlled pilot study with a study size of 50 patients. Results will be utilized to plan a larger scale study. Background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease SSI although this has not been conducted in this population of patients (lumbar spine fusion) to date. A decrease in SSI with Irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. It will be important to know the effect if any of Irrisept on fusion rates. This study will provide valuable information that may assist in future treatment and prevention of SSI in lumbar spinal fusion patients.

Official Title
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Irrisept Spinal Fusion Pilot Study Protocol

Conditions
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Lumbar Spine Disease

Intervention / Treatment
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* Device: Irrisept Irrigation solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels) Exclusion Criteria: Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single Group Assignment
Interventional Model Description: This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normal saline control arm<br>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. | Device: Irrisept Irrigation solution<br>* 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 v. Normal saline irrigation will be used alone in control subjects at the same time points.<br>|
| Active Comparator: Irrisept irrigation solution<br>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 | Device: Irrisept Irrigation solution<br>* 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 v. Normal saline irrigation will be used alone in control subjects at the same time points.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative surgical site infections | Postop SSI | assessed for change at 1 month | 
| Postoperative surgical site infections | postop SSI | assessed for change at 3 months | 
| Postoperative surgical site infections | postop SSI | assessed for change at 6 months | 
| Postoperative surgical site infections | postop SSI | assessed for change at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rates after surgery | fusion rates after surgery with irrisept vs saline irrigation | assessed at 1 month | 
| Fusion rates after surgery | fusion rates after surgery with irrisept vs saline irrigation | assessed for change at 3 months | 
| Fusion rates after surgery | fusion rates after surgery with irrisept vs saline irrigation | assessed for change at 6 months | 
| Fusion rates after surgery | fusion rates after surgery with irrisept vs saline irrigation | assessed for change at 12 months | 
| Patient outcome measures | Visual Analog Score for pain measuring patient outcomes in both study arms | assessed at 1 month | 
| Patient outcome measures | Visual Analog Score for pain measuring patient outcomes in both study arms | assessed at 3 months | 
| Patient outcome measures | Visual Analog Score for pain measuring patient outcomes in both study arms | assessed at 6 months | 
| Patient outcome measures | Visual Analog Score for pain measuring patient outcomes in both study arms | assessed at 12 months | 
| Patient outcome measures | Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms | assessed at 1 month | 
| Patient outcome measures | Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms | assessed at 3 months | 
| Patient outcome measures | Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms | assessed at 6 months | 
| Patient outcome measures | Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms | assessed at 12 months | 
| Patient outcome measures | Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms | assessed at 1 month | 
| Patient outcome measures | Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms | assessed at 3 months | 
| Patient outcome measures | Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms | assessed at 6 months | 
| Patient outcome measures | Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms | assessed at 12 months |