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

Lumbar Spine Degeneration Clinical Trial

— Irrisept  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05408923
• Other study ID #: 2083162
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2022
• Est. completion date: July 2026

Study information

• Verified date: December 2022
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spine Degeneration
• Lumbar Spine Degeneration

Intervention

Drug:
• saline 0.9%
Control group will get normal saline for irrigation throughout the case.
• (0.05% chlorhexidine gluconate (CHG) in sterile water)
Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound healing	Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test	90 days after surgery
Secondary	Wound complications	Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test.	90 days after surgery