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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: Recruiting NA study of Surgical Site Infection and Spine Surgery, sponsored by Rhode Island Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Development of infection after index spinal instrumentation
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 |
What NCT06439953 shows while recruiting
NCT06439953 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 560-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06439953's enrollment target sits among peer trials
200 16th of 25 higher than 10 of 25 other Surgical Site Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Site Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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