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Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery

NCT05408923 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-12-27

No results posted yet for this study

Summary

To compare post-operative wound complications in patients randomized to normal saline versus Irrisept solution and any other adverse reactions from the solution.

Conditions

  • Lumbar Spine Degeneration
  • Cervical Spine Degeneration

Interventions

DRUG

saline 0.9%

Control group will get normal saline for irrigation throughout the case.

DRUG

(0.05% chlorhexidine gluconate (CHG) in sterile water)

Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Don Kim Moore, MD · University of Missouri - Missouri Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-31
Primary Completion
2025-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408923 on ClinicalTrials.gov