Recruiting

Irrisept & Vancomycin

Sponsor:

Rhode Island Hospital

Code:

NCT06439953

Conditions

Post-Op Complication

Spine Surgery

Site Infection

Surgical Site Infection

Spinal Instrumentation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chlorhexidine gluconate solution

Vancomycin

Study Details

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

Study ID

NCT06439953

Start date

Oct 1, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Irrisept Irrigation

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

active comparator: Vancomycin-saline Irrigation

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

Interventions

Chlorhexidine gluconate solution

Evaluating the prophylactic use of Irrisept irrigation alone

Vancomycin

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

Primary outcome measure

  • Occurrence of surgical site infection [ Time Frame: 90 days post-operatively ]

Central Contacts and Locations

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Jared S. Fridley, MD

More Information

Sponsor

Rhode Island Hospital

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-08-14.