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Irrisept Spinal Fusion Pilot Study Protocol
Sponsor: University of Kansas Medical Center
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.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-06-06
Completion Date
2024-12
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
Irrisept 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.
Locations (1)
The University of Kansas Medical Center
Kansas City, Kansas, United States