Irrisept Solution for Instrumented Spine Surgery

Official title

Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation

Overview

Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.

Detailed description

Spinal instrumentation remains the standard of care in the treatment of various traumatic, oncologic, and degenerative spinal pathologies, often requiring the implantation of hardware to stabilize the bony column. In the setting of an aging patient population and expanding indications for instrumentation in younger patients, the number of spinal operations performed has risen substantially within the past decade. Although these procedures have proven to enhance patient quality of life, spinal instrumentation is not without post-operative complication, most notable of which are surgical site infection, seroma formation, and wound breakdown. Such complications can result in notable negative sequelae. Recurrent seroma may compress underlying neurologic structures or increase pressure along the incision, thereby precipitating wound dehiscence and inoculation of the surgical site with pathogenic organisms. Deep space infections often result in prolonged hospitalization, long-term suppressive antibiotic therapy, hardware removal, and permanent disability, which increases cost burden at the patient and hospital level. As such, preventative strategies to reduce the rate of complications following spinal instrumentation remain paramount. Within recent years, attention has turned to various irrigation methods to terminally sterilize prosthetic devices and wound beds, thereby minimizing bacterial colonization and biofilm formation that would otherwise predispose infection.

Irrisept (Irrimax Corporation, Gainesville, Florida) is a solution comprised of 0.05% chlorhexidine gluconate in 99.95% sterile water administered through a proprietary, low-pressure lavage mechanism that has demonstrated efficacy as a bacteriocidal agent in orthopedic hip and knee arthroplasty procedures. Whereas other antiseptic irrigation solutions, such as vancomycin-saline lavage, are routinely used to prevent surgical site infection, relative inertness against gram negative organisms and potential predisposition toward seroma formation render them non-ideal for use in spine surgery. Despite the utility of dilute chlorhexidine gluconate as a prophylactic irrigant, there exist gaps in knowledge with regard to the efficacy of Irrisept to prevent post-operative complications following spinal instrumentation. The central hypothesis of this proposal is that prophylactic use of Irrisept irrigation will result in fewer surgical site infections, clinically significant seromas, and gram negative or atypical infections when compared to standard of care irrigation (vancomycin-saline solution with or without topical vancomycin powder).

Proposed is a prospective, randomized controlled trial comparing rates of post-operative complications following use of Irrisept irrigation alone versus vancomycin-saline lavage with or without topical vancomycin powder (standard of care) in patients aged 18 years or older who undergo posterior cervical, thoracic, lumbar, and/or sacral spinal instrumentation for various indications (deformity, malignancy, degenerative pathology, and trauma) at Rhode Island Hospital.

Interventions

• Device Chlorhexidine gluconate solution
  Evaluating the prophylactic use of Irrisept irrigation alone
• Drug Vancomycin
  Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin

Primary outcome measures

• Occurrence of surgical site infection [Time frame: 90 days post-operatively]

Secondary outcome measures (7)

• Mortality [Time frame: 12 months post-operatively]
• Duration of index hospitalization [Time frame: 12 months post-operatively]
• Occurrence of 30-day readmission [Time frame: 30 days post-operatively]
• Occurrence of wound dehiscence [Time frame: 12 months post-operatively]
• Time to closed suction drain removal [Time frame: 12 months post-operatively]
• Presence of atypical micro-organisms on wound fluid laboratory culture [Time frame: 12 months post-operatively]
• Cost of spine surgery care from surgery to 12-month post-operative follow up [Time frame: 12 months post-operatively]

Eligibility criteria

Inclusion criteria

• Age: 18+ years old
• Indications: deformity, oncologic, degenerative, trauma
• Standard layer-by-layer closure
• Locoregional flap-based closure

Exclusion criteria

• Acute/chronic open wounds (spine or non-spine)
• On-going non-spinal infection within 30 days of index operation
• Concurrent antibiotic use (for spine or non-spine infections)
• History of prior spinal infection
• Allergy to vancomycin or chlorhexidine
• Suspicion for osteomyelitis
• Other surgery within 90 days post-operatively fromm index
• Concurrent enrollment in other trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Rhode Island Hospital — Providence

Publications

• Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010 Apr 7;303(13):1259-65. doi: 10.1001/jama.2010.338. PMID 20371784
• Martin BI, Mirza SK, Spina N, Spiker WR, Lawrence B, Brodke DS. Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States, 2004 to 2015. Spine (Phila Pa 1976). 2019 Mar 1;44(5):369-376. doi: 10.1097/BRS.0000000000002822. PMID 30074971
• Jain NK, Dao K, Ortiz AO. Radiologic evaluation and management of postoperative spine paraspinal fluid collections. Neuroimaging Clin N Am. 2014 May;24(2):375-89. doi: 10.1016/j.nic.2014.01.001. PMID 24792615
• Blumberg TJ, Woelber E, Bellabarba C, Bransford R, Spina N. Predictors of increased cost and length of stay in the treatment of postoperative spine surgical site infection. Spine J. 2018 Feb;18(2):300-306. doi: 10.1016/j.spinee.2017.07.173. Epub 2017 Jul 21. PMID 28739477
• de Lissovoy G, Fraeman K, Hutchins V, Murphy D, Song D, Vaughn BB. Surgical site infection: incidence and impact on hospital utilization and treatment costs. Am J Infect Control. 2009 Jun;37(5):387-397. doi: 10.1016/j.ajic.2008.12.010. Epub 2009 Apr 23. PMID 19398246
• Torres KA, Konrade E, White J, Tavares Junior MCM, Bunch JT, Burton D, Jackson RS, Birlingmair J, Carlson BB. Irrigation techniques used in spine surgery for surgical site infection prophylaxis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2022 Aug 26;23(1):813. doi: 10.1186/s12891-022-05763-2. PMID 36008858
• Yao R, Tan T, Tee JW, Street J. Prophylaxis of surgical site infection in adult spine surgery: A systematic review. J Clin Neurosci. 2018 Jun;52:5-25. doi: 10.1016/j.jocn.2018.03.023. Epub 2018 Mar 30. PMID 29609860
• Kapadia BH, Zhou PL, Jauregui JJ, Mont MA. Does Preadmission Cutaneous Chlorhexidine Preparation Reduce Surgical Site Infections After Total Knee Arthroplasty? Clin Orthop Relat Res. 2016 Jul;474(7):1592-8. doi: 10.1007/s11999-016-4767-6. PMID 26956247

Identifiers

NCT: NCT06439953 · 2095643

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗