Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery

Phase 4

Withdrawn

• Conditions: Cervical Spine Degeneration; Lumbar Spine Degeneration
• Interventions: Drug: saline 0.9%; Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)

• Registration Number: NCT05408923
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.

Detailed Description

Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a need for isolated open posterior spine procedures using a posterior open approach.
• Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
• >18 years old and able to provide informed consent

Exclusion Criteria

• Ongoing or suspected infection
• Revisions of failed back surgeries
• Documented allergy to CHG or CHG products
• Pregnancy - qualitative beta human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
• Prisoners or wards of the state
• Unable to consent to research study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	saline 0.9%	Patients in this group will be given the placebo (sterile saline).
Irrisept	(0.05% chlorhexidine gluconate (CHG) in sterile water)	Patients in this group will be given the study drug (Irrisept).

Primary Outcome Measures

Name	Time	Method
Center for Disease Control (CDC)-defined 90-day surgical site infection incidence	90 days after surgery	Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test.

Secondary Outcome Measures

Name	Time	Method
Wound healing	90 days after surgery	Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test
Wound complications	90 days after surgery	Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test.

Trial Locations

Locations (1)

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States