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Enrolling by invitation NCT05011942

Irrisept Spinal Fusion Pilot Study Protocol

No phase Interventional Lumbar Spine Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Irrisept Irrigation solution.
Who it may be relevant to
Registry conditions: Lumbar Spine Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.

Detailed description

This is a randomized controlled pilot study with a study size of 50 patients. Results will be utilized to plan a larger scale study. Background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease SSI although this has not been conducted in this population of patients (lumbar spine fusion) to date. A decrease in SSI with Irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. It will be important to know the effect if any of Irrisept on fusion rates. This study will provide valuable information that may assist in future treatment and prevention of SSI in lumbar spinal fusion patients.

Interventions

  • Device Irrisept Irrigation solution
    ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects v. Normal saline irrigation will be used

Primary outcome measures

  • Postoperative surgical site infections [Time frame: assessed for change at 1 month]
  • Postoperative surgical site infections [Time frame: assessed for change at 3 months]
  • Postoperative surgical site infections [Time frame: assessed for change at 6 months]
  • Postoperative surgical site infections [Time frame: assessed for change at 12 months]
Secondary outcome measures (12)
  • Fusion rates after surgery [Time frame: assessed at 1 month]
  • Fusion rates after surgery [Time frame: assessed for change at 3 months]
  • Fusion rates after surgery [Time frame: assessed for change at 6 months]
  • Fusion rates after surgery [Time frame: assessed for change at 12 months]
  • Patient outcome measures [Time frame: assessed at 1 month]
  • Patient outcome measures [Time frame: assessed at 3 months]
  • Patient outcome measures [Time frame: assessed at 6 months]
  • Patient outcome measures [Time frame: assessed at 12 months]
  • Patient outcome measures [Time frame: assessed at 1 month]
  • Patient outcome measures [Time frame: assessed at 3 months]
  • Patient outcome measures [Time frame: assessed at 6 months]
  • Patient outcome measures [Time frame: assessed at 12 months]

Eligibility criteria

Inclusion criteria

  • Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)

Exclusion criteria

  • Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT05011942 · 146827

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗