Irrisept Spinal Fusion Pilot Study Protocol

University of Kansas

Status: Invitation-only

Conditions: Lumbar Spine Disease

Treatments: Device: Irrisept Irrigation solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05011942

146827

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

normal saline control arm

Placebo Comparator group

Description:

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.

Treatment:

Device: Irrisept Irrigation solution

Irrisept irrigation solution

Active Comparator group

Description:

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

Treatment:

Device: Irrisept Irrigation solution