BridgeMD
New treatment option for Post-Op Complication
Official title Irrisept Solution for Instrumented Spine Surgery
ClinicalTrials.gov ID: NCT06439953
What this study is testing
What is Vancomycin?
Vancomycin is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for post-op complication.
Also referred to as Vancomycin-saline.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: 18+ years old
- Indications: deformity, oncologic, degenerative, trauma
- Standard layer-by-layer closure
- Locoregional flap-based closure
You likely can't join if
- Acute/chronic open wounds (spine or non-spine)
- On-going non-spinal infection within 30 days of index operation
- Concurrent antibiotic use (for spine or non-spine infections)
- History of prior spinal infection
- Allergy to vancomycin or chlorhexidine
- Suspicion for osteomyelitis
See the full eligibility criteria
- Age: 18+ years old
- Indications: deformity, oncologic, degenerative, trauma
- Standard layer-by-layer closure
- Locoregional flap-based closure
- Acute/chronic open wounds (spine or non-spine)
- On-going non-spinal infection within 30 days of index operation
- Concurrent antibiotic use (for spine or non-spine infections)
- History of prior spinal infection
- Allergy to vancomycin or chlorhexidine
- Suspicion for osteomyelitis
- Other surgery within 90 days post-operatively fromm index
- Concurrent enrollment in other trial
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.