RECRUITING

Irrisept Solution for Instrumented Spine Surgery

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.

Study Overview

Study Details

Study 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.

Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation

Irrisept Solution for Instrumented Spine Surgery

Condition
Post-Op Complication
Intervention / Treatment

-

Contacts and Locations

Providence

Rhode Island Hospital, Providence, Rhode Island, United States, 02903

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rhode Island Hospital,

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

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

Study Record Dates

2026-09-30