RECRUITING

Irrisept Solution for Instrumented Spine Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation

Quick Facts

Study Start:2024-10-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06439953

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: 18+ years old
  2. * Indications: deformity, oncologic, degenerative, trauma
  3. * Standard layer-by-layer closure
  4. * Locoregional flap-based closure
  1. * Acute/chronic open wounds (spine or non-spine)
  2. * On-going non-spinal infection within 30 days of index operation
  3. * Concurrent antibiotic use (for spine or non-spine infections)
  4. * History of prior spinal infection
  5. * Allergy to vancomycin or chlorhexidine
  6. * Suspicion for osteomyelitis
  7. * Other surgery within 90 days post-operatively fromm index
  8. * Concurrent enrollment in other trial

Contacts and Locations

Study Contact

Alexander Chernysh
CONTACT
401-444-9868
AChernysh@lifespan.org
Owen Leary
CONTACT
401-6068388
owen.leary@lifespan.org

Principal Investigator

Jared S. Fridley, MD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital
Albert S. Woo, MD
PRINCIPAL_INVESTIGATOR
Rhode Island Hospital

Study Locations (Sites)

Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

  • Jared S. Fridley, MD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital
  • Albert S. Woo, MD, PRINCIPAL_INVESTIGATOR, Rhode Island Hospital

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 Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Post-Op Complication
  • Spine Surgery
  • Site Infection
  • Surgical Site Infection
  • Spinal Instrumentation
  • Index Spinal Instrumentation
  • Layer-by-Layer Closure
  • Locoregional Flap-Based Closure