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RECRUITING
NCT06439953
NA

Irrisept Solution for Instrumented Spine Surgery

Sponsor: Rhode Island Hospital

View on ClinicalTrials.gov

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.

Official title: Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-10-01

Completion Date

2026-09-30

Last Updated

2024-11-20

Healthy Volunteers

No

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

Locations (1)

Rhode Island Hospital

Providence, Rhode Island, United States