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

NCT05408923 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2083162
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spine Degeneration; Cervical Spine Degeneration

Outcome Measures

Primary Outcomes (1)

• Center for Disease Control (CDC)-defined 90-day surgical site infection incidence

  Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test.

  90 days after surgery

Secondary Outcomes (2)

• Wound healing

  90 days after surgery

• Wound complications

  90 days after surgery

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Drug: saline 0.9%

Irrisept

ACTIVE COMPARATOR

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

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

Interventions

saline 0.9% DRUG

Control group will get normal saline for irrigation throughout the case.

Also known as: sterile saline

Placebo Group

(0.05% chlorhexidine gluconate (CHG) in sterile water) DRUG

Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.

Also known as: Irrisept

Irrisept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65211, United States

Location

Related Publications (8)

• Magill SS, Hellinger W, Cohen J, Kay R, Bailey C, Boland B, Carey D, de Guzman J, Dominguez K, Edwards J, Goraczewski L, Horan T, Miller M, Phelps M, Saltford R, Seibert J, Smith B, Starling P, Viergutz B, Walsh K, Rathore M, Guzman N, Fridkin S. Prevalence of healthcare-associated infections in acute care hospitals in Jacksonville, Florida. Infect Control Hosp Epidemiol. 2012 Mar;33(3):283-91. doi: 10.1086/664048. Epub 2012 Jan 12.

  PMID: 22314066 BACKGROUND

• Chahoud J, Kanafani Z, Kanj SS. Surgical site infections following spine surgery: eliminating the controversies in the diagnosis. Front Med (Lausanne). 2014 Mar 24;1:7. doi: 10.3389/fmed.2014.00007. eCollection 2014.

  PMID: 25705620 BACKGROUND

• Silber JS, Anderson DG, Vaccaro AR, Anderson PA, McCormick P; NASS. Management of postprocedural discitis. Spine J. 2002 Jul-Aug;2(4):279-87. doi: 10.1016/s1529-9430(02)00203-6.

  PMID: 14589480 BACKGROUND

• Rechtine GR, Bono PL, Cahill D, Bolesta MJ, Chrin AM. Postoperative wound infection after instrumentation of thoracic and lumbar fractures. J Orthop Trauma. 2001 Nov;15(8):566-9. doi: 10.1097/00005131-200111000-00006.

  PMID: 11733673 BACKGROUND

• Whitmore RG, Stephen J, Stein SC, Campbell PG, Yadla S, Harrop JS, Sharan AD, Maltenfort MG, Ratliff JK. Patient comorbidities and complications after spinal surgery: a societal-based cost analysis. Spine (Phila Pa 1976). 2012 May 20;37(12):1065-71. doi: 10.1097/BRS.0b013e31823da22d.

  PMID: 22045005 BACKGROUND

• 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.

  PMID: 31609802 BACKGROUND

• 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.

  PMID: 29098088 BACKGROUND

• 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.

  PMID: 20433302 BACKGROUND

MeSH Terms

Interventions

Sodium Chloride; chlorhexidine gluconate; Chromogranins

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Study Officials

• Don Kim Moore, MD

  University of Missouri - Missouri Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROF, AST CLINICAL DEPT

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 7, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)