Clinical trial NCT06439953: Irrisept Solution for Instrumented Spine Surgery
Official title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Op Complication
Spine Surgery
Site Infection
Surgical Site Infection
Spinal Instrumentation
Index Spinal Instrumentation
Layer-by-Layer Closure
Locoregional Flap-Based Closure
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Occurrence of surgical site infection
timeFrame: 90 days post-operatively
Secondary outcomes:
measure: Mortality
timeFrame: 12 months post-operatively
measure: Duration of index hospitalization
timeFrame: 12 months post-operatively
measure: Occurrence of 30-day readmission
timeFrame: 30 days post-operatively
measure: Occurrence of wound dehiscence
timeFrame: 12 months post-operatively
measure: Time to closed suction drain removal
timeFrame: 12 months post-operatively
measure: Presence of atypical micro-organisms on wound fluid laboratory culture
timeFrame: 12 months post-operatively
measure: Cost of spine surgery care from surgery to 12-month post-operative follow up
timeFrame: 12 months post-operatively
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Jared S. Fridley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Albert S. Woo, MD
role: PRINCIPAL_INVESTIGATOR
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