Cervical Spine Degeneration, Lumbar Spine Degeneration
Conditions
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.
Interventions
DRUGsaline 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.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Irrisept can be differentiated visually from normal saline. Patients will be informed in the consent that they will be blinded to the treatment they are randomized to throughout the study.
Intervention model description
Patients will be randomized preoperatively to the study group (Irrisept) versus the control group (sterile saline irrigation). Standard betadine and/or chloraprep solution will be used to prep the patient. Control group will get normal saline for irrigation throughout the case while study group will be irrigated with the Irrisept solution intermittently throughout the procedure per surgeon discretion. No Vancomycin powder will be used in both groups at the time of closure. Standard closure will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed