Lumbar Spine Disease
Conditions
Brief summary
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
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.
Interventions
DEVICEIrrisept Irrigation solution
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.
Sponsors
Irrimax Corporation
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative surgical site infections | assessed for change at 1 month | Postop SSI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fusion rates after surgery | assessed at 1 month | fusion rates after surgery with irrisept vs saline irrigation |
| Patient outcome measures | assessed at 1 month | Visual Analog Score for pain measuring patient outcomes in both study arms |
Countries
United States
Outcome results
None listed