Clinical trial NCT05011942: Irrisept Spinal Fusion Pilot Study Protocol
Official title: Irrisept Spinal Fusion Pilot Study Protocol
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lumbar Spine Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2021-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative surgical site infections
timeFrame: assessed for change at 1 month
measure: Postoperative surgical site infections
timeFrame: assessed for change at 3 months
measure: Postoperative surgical site infections
timeFrame: assessed for change at 6 months
measure: Postoperative surgical site infections
timeFrame: assessed for change at 12 months
Secondary outcomes:
measure: Fusion rates after surgery
timeFrame: assessed at 1 month
measure: Fusion rates after surgery
timeFrame: assessed for change at 3 months
measure: Fusion rates after surgery
timeFrame: assessed for change at 6 months
measure: Fusion rates after surgery
timeFrame: assessed for change at 12 months
measure: Patient outcome measures
timeFrame: assessed at 1 month
measure: Patient outcome measures
timeFrame: assessed at 3 months
measure: Patient outcome measures
timeFrame: assessed at 6 months
measure: Patient outcome measures
timeFrame: assessed at 12 months
measure: Patient outcome measures
timeFrame: assessed at 1 month
measure: Patient outcome measures
timeFrame: assessed at 3 months
measure: Patient outcome measures
timeFrame: assessed at 6 months
measure: Patient outcome measures
timeFrame: assessed at 12 months
measure: Patient outcome measures
timeFrame: assessed at 1 month
measure: Patient outcome measures
timeFrame: assessed at 3 months
measure: Patient outcome measures
timeFrame: assessed at 6 months
measure: Patient outcome measures
timeFrame: assessed at 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
Study officials:
References: