Irrisept Solution for Instrumented Spine Surgery

November 18, 2024 updated by: Rhode Island Hospital

Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Contact:
          • Jared S. Fridley, MD
        • Contact:
          • Albert S. Woo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irrisept Irrigation
Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.
Device: Chlorhexidine gluconate solution
Evaluating the prophylactic use of Irrisept irrigation alone
Other Names:
  • Irrisept irrigation
Active Comparator: Vancomycin-saline Irrigation
Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.
Drug: Vancomycin
Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin
Other Names:
  • Vancomycin-saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of surgical site infection
Time Frame: 90 days post-operatively
Development of infection after index spinal instrumentation
90 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months post-operatively
Capture mortality rates after index spinal instrumentation
12 months post-operatively
Duration of index hospitalization
Time Frame: 12 months post-operatively
Capture duration of index hospitalization after index spinal instrumentation
12 months post-operatively
Occurrence of 30-day readmission
Time Frame: 30 days post-operatively
Capture 30-day readmission rates after index spinal instrumentation
30 days post-operatively
Occurrence of wound dehiscence
Time Frame: 12 months post-operatively
Capture all incidences of wound dehiscence after index spinal instrumentation
12 months post-operatively
Time to closed suction drain removal
Time Frame: 12 months post-operatively
Capture the time interval to closed suction drain removal after index spinal instrumentation
12 months post-operatively
Presence of atypical micro-organisms on wound fluid laboratory culture
Time Frame: 12 months post-operatively
Capture the presence of atypical micro-organisms after index spinal instrumentation
12 months post-operatively
Cost of spine surgery care from surgery to 12-month post-operative follow up
Time Frame: 12 months post-operatively
Consider associated total costs of spinal instrumentation after index spinal instrumentation by comparing total surgical costs and post-surgical outcome expenses of those with and without Irrisept irrigation use
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Jared S. Fridley, MD, Rhode Island Hospital
  • Principal Investigator: Albert S. Woo, MD, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2095643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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