An interventional study of Irrisept Irrigation solution in Lumbar Spine Disease, sponsored by University of Kansas Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 106 interventional studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
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Exclusion Criteria:
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
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
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.
Postoperative surgical site infections
Postop SSI
Time frame: assessed for change at 1 month
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 3 months
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 6 months
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 12 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed at 1 month
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 3 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 6 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 12 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 1 month
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 12 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 1 month
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 12 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 1 month
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Dec 2024, 30 months after the start.
Of 40 non-industry interventional studies with no phase under Spinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 30 months is above that.
Counting every sponsor, half of 43 studies reached it within 26 months; a quarter within 16 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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