Irrisept Spinal Fusion Pilot Study Protocol

Not Applicable

• Conditions: Lumbar Spine Disease
• Interventions: Device: Irrisept Irrigation solution

• Registration Number: NCT05011942
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study First Submitted: 2021-07-30
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18
• Study Start: 2021-09
• Primary Completion: 2023-12
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irrisept irrigation solution	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
normal saline control arm	Irrisept Irrigation solution	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.

Primary Outcome Measures

Name	Time	Method
Postoperative surgical site infections	assessed for change at 12 months	postop SSI

Secondary Outcome Measures

Name	Time	Method
Fusion rates after surgery	assessed for change at 12 months	fusion rates after surgery with irrisept vs saline irrigation
Patient outcome measures	assessed at 12 months	Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States