RecruitingNot ApplicableNCT06439953

Irrisept Solution for Instrumented Spine Surgery

Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation


Sponsor

Rhode Island Hospital

Enrollment

200 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Chlorhexidine gluconate solution and a drug called Vancomycin for people with index spinal instrumentation, layer-by-layer closure, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEChlorhexidine gluconate solution

Evaluating the prophylactic use of Irrisept irrigation alone

DRUGVancomycin

Evaluating the use of versus vancomycin-saline irrigation with or without topical vancomycin


Locations(1)

Rhode Island Hospital

Providence, Rhode Island, United States

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NCT06439953


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