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Irrisept Solution for Instrumented Spine Surgery

NCT06439953 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Jared S. Fridley, MD · Rhode Island Hospital

  • Albert S. Woo, MD · Rhode Island Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06439953 on ClinicalTrials.gov