Lumbar Spine DiseaseNCT05011942
Irrisept Spinal Fusion Pilot Study Protocol
A study testing Irrisept Irrigation solution in people with Lumbar Spine Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lumbar Spine Disease
- What is being tested?
- Irrisept Irrigation solution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)
Who cannot join
- Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66106
About this study
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.
Read the 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.
- Conditions
- Lumbar Spine Disease
- Being tested
- Irrisept Irrigation solution
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisept Irrigation solutionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| normal saline control arm | Placebo comparator | ii. normal saline used after initial skin incision 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. Receives: Device: Irrisept Irrigation solution |
| Irrisept irrigation solution | Active comparator | 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 Receives: Device: Irrisept Irrigation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative surgical site infections
Postop SSI
Measured: assessed for change at 1 month
Postoperative surgical site infections
postop SSI
Measured: assessed for change at 3 months
Postoperative surgical site infections
postop SSI
Measured: assessed for change at 6 months
Postoperative surgical site infections
postop SSI
Measured: assessed for change at 12 months
Secondary outcomes (16)
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Measured: assessed at 1 month
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Measured: assessed for change at 3 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Measured: assessed for change at 6 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Measured: assessed for change at 12 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Measured: assessed at 1 month
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Measured: assessed at 3 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Measured: assessed at 6 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Measured: assessed at 12 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 1 month
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 3 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 6 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 12 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 1 month
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 3 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 6 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Measured: assessed at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start6 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Irrimax Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011942
- Sponsor's protocol ID
- 146827
- Status last verified
- Sep 2024
- First submitted
- 30 Jul 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irrisept Spinal Fusion Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT05011942
- Acronym / sponsor ID
- 146827
- Conditions
- Lumbar Spine Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Irrimax Corporation
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized 1:1 treatment of placebo or standard of care irrigation and Irrisept solution.
| Arm | Type | Receives |
|---|---|---|
| normal saline control arm | Placebo comparator | Device: Irrisept Irrigation solutionii. normal saline used after initial skin incision 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. |
| Irrisept irrigation solution | Active comparator | Device: Irrisept Irrigation solutionii. 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)
Key exclusion criteria (1 listed)
- Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrisept Irrigation solutionii. 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. | Device | Irrisept irrigation solution, normal saline control arm |
Primary outcome
Postoperative surgical site infections
Time frame: assessed for change at 1 month
Postop SSI
Postoperative surgical site infections
Time frame: assessed for change at 3 months
postop SSI
Postoperative surgical site infections
Time frame: assessed for change at 6 months
postop SSI
Postoperative surgical site infections
Time frame: assessed for change at 12 months
postop SSI
16 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irrisept Irrigation solution in people with Lumbar Spine Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative surgical site infections (time frame: assessed for change at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.