Clinical trial NCT05408923: Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
Official title: Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Lumbar Spine Degeneration
Cervical Spine Degeneration
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Center for Disease Control (CDC)-defined 90-day surgical site infection incidence
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Wound healing
timeFrame: 90 days after surgery
measure: Wound complications
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri - Missouri Orthopaedic Institute
name: Don Kim Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Onishi Y, Masuda K, Tozawa K, Karita T. Outcomes of an Intraoperative Povidone-Iodine Irrigation Protocol in Spinal Surgery for Surgical Site Infection Prevention. Clin Spine Surg. 2019 Dec;32(10):E449-E452. doi: 10.1097/BSD.0000000000000908.
citation: De Luna V, Mancini F, De Maio F, Bernardi G, Ippolito E, Caterini R. Intraoperative Disinfection by Pulse Irrigation with Povidone-Iodine Solution in Spine Surgery. Adv Orthop. 2017;2017:7218918. doi: 10.1155/2017/7218918. Epub 2017 Oct 2.
citation: Watanabe M, Sakai D, Matsuyama D, Yamamoto Y, Sato M, Mochida J. Risk factors for surgical site infection following spine surgery: efficacy of intraoperative saline irrigation. J Neurosurg Spine. 2010 May;12(5):540-6. doi: 10.3171/2009.11.SPINE09308.