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

University of Missouri (MU)

Status and phase: Withdrawn; Phase 4

Conditions: Lumbar Spine Degeneration; Cervical Spine Degeneration

Treatments: Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water); Drug: saline 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT05408923

2083162

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Patients in this group will be given the placebo (sterile saline).

Treatment:

Drug: saline 0.9%

Irrisept

Active Comparator group

Description:

Patients in this group will be given the study drug (Irrisept).

Treatment:

Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)