Irrisept Spinal Fusion Pilot Study Protocol

NAEnrolling by invitationINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 6, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Lumbar Spine Disease
Interventions
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.

Trial Locations (1)

66106

The University of Kansas Medical Center, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Irrimax Corporation

INDUSTRY

lead

University of Kansas Medical Center

OTHER

NCT05011942 - Irrisept Spinal Fusion Pilot Study Protocol | Biotech Hunter | Biotech Hunter