Irrisept Solution for Instrumented Spine Surgery

NCT06439953 | Recruiting FDA Device

• 1 other identifier: 2095643
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Post-Op Complication; Spine Surgery; Site Infection; Surgical Site Infection; Spinal Instrumentation; Index Spinal Instrumentation; Layer-by-Layer Closure; Locoregional Flap-Based Closure

Outcome Measures

Primary Outcomes (1)

• Occurrence of surgical site infection

  Development of infection after index spinal instrumentation

  90 days post-operatively

Secondary Outcomes (7)

• Mortality

  12 months post-operatively

• Duration of index hospitalization

  12 months post-operatively

• Occurrence of 30-day readmission

  30 days post-operatively

• Occurrence of wound dehiscence

  12 months post-operatively

• Time to closed suction drain removal

  12 months post-operatively

Study Arms (2)

Irrisept Irrigation

EXPERIMENTAL

Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.

Device: Chlorhexidine gluconate solution

Vancomycin-saline Irrigation

ACTIVE COMPARATOR

Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.

Drug: Vancomycin

Interventions

Chlorhexidine gluconate solution DEVICE

Evaluating the prophylactic use of Irrisept irrigation alone

Also known as: Irrisept irrigation

Irrisept Irrigation

Vancomycin DRUG

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

Also known as: Vancomycin-saline

Vancomycin-saline Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18+ years old
• Indications: deformity, oncologic, degenerative, trauma
• Standard layer-by-layer closure
• Locoregional flap-based closure

You may not qualify 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
• Other surgery within 90 days post-operatively fromm index
• Concurrent enrollment in other trial

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (18)

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  PMID: 35819733 BACKGROUND

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  PMID: 26424335 BACKGROUND

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MeSH Terms

Conditions

Postoperative Complications; Surgical Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jared S. Fridley, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Albert S. Woo, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Chernysh

CONTACT

401-444-9868; AChernysh@lifespan.org

Owen Leary

CONTACT

401-6068388; owen.leary@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-06

Locations

US (1)