Irrisept Spinal Fusion Pilot Study Protocol

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spine Disease
• Intervention / Treatment: Device: Irrisept Irrigation solution

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66106
      • The University of Kansas Medical Center
      • Principal Investigator: Joshua Bunch, MD
      • Contact: Joshua Bunch, MD; Phone Number: 913-588-6100; Email: jbunch2@kumc.edu
      • Contact: Stephanie Robinson, MS; Phone Number: 9137091416; Email: srobinson6@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: normal saline control arm; 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 v. Normal saline irrigation will be used alone in control subjects at the same time points.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative surgical site infections	Postop SSI	assessed for change at 1 month
Postoperative surgical site infections	postop SSI	assessed for change at 3 months
Postoperative surgical site infections	postop SSI	assessed for change at 6 months
Postoperative surgical site infections	postop SSI	assessed for change at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rates after surgery	fusion rates after surgery with irrisept vs saline irrigation	assessed at 1 month
Fusion rates after surgery	fusion rates after surgery with irrisept vs saline irrigation	assessed for change at 3 months
Fusion rates after surgery	fusion rates after surgery with irrisept vs saline irrigation	assessed for change at 6 months
Fusion rates after surgery	fusion rates after surgery with irrisept vs saline irrigation	assessed for change at 12 months
Patient outcome measures	Visual Analog Score for pain measuring patient outcomes in both study arms	assessed at 1 month
Patient outcome measures	Visual Analog Score for pain measuring patient outcomes in both study arms	assessed at 3 months
Patient outcome measures	Visual Analog Score for pain measuring patient outcomes in both study arms	assessed at 6 months
Patient outcome measures	Visual Analog Score for pain measuring patient outcomes in both study arms	assessed at 12 months
Patient outcome measures	Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms	assessed at 1 month
Patient outcome measures	Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms	assessed at 3 months
Patient outcome measures	Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms	assessed at 6 months
Patient outcome measures	Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms	assessed at 12 months
Patient outcome measures	Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms	assessed at 1 month
Patient outcome measures	Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms	assessed at 3 months
Patient outcome measures	Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms	assessed at 6 months
Patient outcome measures	Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms	assessed at 12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Irrimax Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: July 30, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: 146827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No