NCT05408923

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Spine Degeneration
• Cervical Spine Degeneration

Interventions

Type	Name	Description
DRUG	saline 0.9%	Control group will get normal saline for irrigation throughout the case.
DRUG	(0.05% chlorhexidine gluconate (CHG) in sterile water)	Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2022-06-07
• Last updated: 2022-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study