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Enrolling by Invitation

NCT Number: NCT05011942

Irrisept Spinal Fusion Pilot Study Protocol

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.

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Key information

Conditions

Lumbar Spine Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irrisept Irrigation solution

Device

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 alone in control subjects at the same time points.

Primary outcomes

  1. Postoperative surgical site infections

    Time frame: assessed for change at 1 month

    Postop SSI

  2. Postoperative surgical site infections

    Time frame: assessed for change at 3 months

    postop SSI

  3. Postoperative surgical site infections

    Time frame: assessed for change at 6 months

    postop SSI

  4. Postoperative surgical site infections

    Time frame: assessed for change at 12 months

    postop SSI

Secondary outcomes

  1. Fusion rates after surgery

    Time frame: assessed at 1 month

    fusion rates after surgery with irrisept vs saline irrigation

  2. Fusion rates after surgery

    Time frame: assessed for change at 3 months

    fusion rates after surgery with irrisept vs saline irrigation

  3. Fusion rates after surgery

    Time frame: assessed for change at 6 months

    fusion rates after surgery with irrisept vs saline irrigation

  4. Fusion rates after surgery

    Time frame: assessed for change at 12 months

    fusion rates after surgery with irrisept vs saline irrigation

  5. Patient outcome measures

    Time frame: assessed at 1 month

    Visual Analog Score for pain measuring patient outcomes in both study arms

  6. Patient outcome measures

    Time frame: assessed at 3 months

    Visual Analog Score for pain measuring patient outcomes in both study arms

  7. Patient outcome measures

    Time frame: assessed at 6 months

    Visual Analog Score for pain measuring patient outcomes in both study arms

  8. Patient outcome measures

    Time frame: assessed at 12 months

    Visual Analog Score for pain measuring patient outcomes in both study arms

  9. Patient outcome measures

    Time frame: assessed at 1 month

    Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms

  10. Patient outcome measures

    Time frame: assessed at 3 months

    Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms

  11. Patient outcome measures

    Time frame: assessed at 6 months

    Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms

  12. Patient outcome measures

    Time frame: assessed at 12 months

    Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms

  13. Patient outcome measures

    Time frame: assessed at 1 month

    Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms

  14. Patient outcome measures

    Time frame: assessed at 3 months

    Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms

  15. Patient outcome measures

    Time frame: assessed at 6 months

    Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms

  16. Patient outcome measures

    Time frame: assessed at 12 months

    Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Irrimax Corporation

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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