Irrisept Spinal Fusion Pilot Study Protocol

NCT05011942 | Enrolling By Invitation FDA Device

• 1 other identifier: 146827
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Disease

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Fusion rates after surgery

  assessed at 1 month

• Fusion rates after surgery

  assessed for change at 3 months

• Fusion rates after surgery

  assessed for change at 6 months

• Fusion rates after surgery

  assessed for change at 12 months

• Patient outcome measures

  assessed at 1 month

Study Arms (2)

normal saline control arm

PLACEBO COMPARATOR

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

Irrisept irrigation solution

ACTIVE COMPARATOR

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

Interventions

Irrisept Irrigation solution DEVICE

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.

Irrisept irrigation solution; normal saline control arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)

You may not qualify if:

• Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Irrimax Corporation: collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66106, United States

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 18, 2021
• Study Start: June 6, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)