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NCT06439953 · ClinicalTrials.gov registry record · NA
Irrisept Solution for Instrumented Spine Surgery
A NA study of Surgical Site Infection and Spine Surgery, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06439953 is a NA study of Surgical Site Infection and Spine Surgery that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 200 participants, below the 560-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06439953, a NA study of Surgical Site Infection and Spine Surgery, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Vancomycin
- DEVICE Chlorhexidine gluconate solution
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06439953
The ClinicalTrials.gov registry entry for NCT06439953 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 560-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (64% lower). The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which Vancomycin is the first listed.
NCT06439953 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06439953 about?
NCT06439953 is a clinical study titled "Irrisept Solution for Instrumented Spine Surgery". 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...
What is the current status of trial NCT06439953?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-10-01. Estimated completion is 2026-09-30.
What conditions does trial NCT06439953 study?
This clinical trial studies the following conditions: Surgical Site Infection, Spine Surgery, Post-Op Complication, Site Infection, Spinal Instrumentation.
What interventions are being tested in trial NCT06439953?
The interventions under investigation include: Vancomycin (DRUG), Chlorhexidine gluconate solution (DEVICE).
Who is sponsoring clinical trial NCT06439953?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06439953 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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