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Lumbar Spine DegenerationPhase 4IrriseptNCT05408923

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

A Phase 4 study testing saline 0.9% and (0.05% chlorhexidine gluconate (CHG) in sterile water) in people with Lumbar Spine Degeneration and Cervical Spine Degeneration, run by University of Missouri-Columbia at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
saline 0.9% and (0.05% chlorhexidine gluconate (CHG) in sterile water)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2022to Jul 2026
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a need for isolated open posterior spine procedures using a posterior open approach.
  • Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
  • >18 years old and able to provide informed consent

Who cannot join

  • Ongoing or suspected infection
  • Revisions of failed back surgeries
  • Documented allergy to CHG or CHG products
  • Pregnancy - qualitative beta human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
  • Prisoners or wards of the state
  • Unable to consent to research study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Missouri Orthopaedic Institute

    Columbia, Missouri, 65211

Other trials in United States

About this study

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

Read the detailed description

Wound complications represent a significant risk factor in spinal surgery, particularly in complex multilevel procedures. Surgical site infections (SSI) are the most common health care-associated infection, accounting for 31% of all hospitalized patients with a health care-associated infection. The reported incidence of SSIs following spine surgery ranges from 0.2% to 18.8%. In one study, each episode of wound infection following spine procedure contributed to a mean increase in the cost of care by $4,067 compared to a non-complicated case. The bacteria can adhere to the implants and tissues to create biofilm made by polysaccharide matrix which makes it challenging to clear the infection. Different irrigation techniques and solutions have been utilized to help limit post-operative wound complications. No studies have compared Irrisept solution to normal saline to see if there is a difference in wound complications for posterior spine surgeries.

Being tested
saline 0.9%, (0.05% chlorhexidine gluconate (CHG) in sterile water)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saline 0.9%Drug

    Also called sterile saline

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

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

    Also called Irrisept

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

Study groups in NCT05408923
Study groupRoleWhat they receive
Placebo GroupPlacebo comparatorPatients in this group will be given the placebo (sterile saline).
Receives: Drug: saline 0.9%
IrriseptActive comparatorPatients in this group will be given the study drug (Irrisept).
Receives: Drug: (0.05% chlorhexidine gluconate (CHG) in sterile water)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Center for Disease Control (CDC)-defined 90-day surgical site infection incidence

    Comparing post-operative surgical site infection incidence between groups for 90 days post-operative using chi-square test.

    Measured: 90 days after surgery

Secondary outcomes (2)

  1. Wound healing

    Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test

    Measured: 90 days after surgery

  2. Wound complications

    Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test.

    Measured: 90 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Why it stopped: It was determined not to be feasible at our site at this time.

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized preoperatively to the study group (Irrisept) versus the control group (sterile saline irrigation). Standard betadine and/or chloraprep solution will be used to prep the patient. Control group will get normal saline for irrigation throughout the case while study group will be irrigated with the Irrisept solution intermittently throughout the procedure per surgeon discretion. No Vancomycin powder will be used in both groups at the time of closure. Standard closure will be performed.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05408923
Sponsor's protocol ID
2083162
Acronym
Irrisept
Status last verified
Dec 2022
First submitted
2 Jun 2022
Last updated
27 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Magill SS, Hellinger W, Cohen J, Kay R, Bailey C, Boland B, Carey D, de Guzman J, Dominguez K, Edwards J, Goraczewski L, Horan T, Miller M, Phelps M, Saltford R, Seibert J, Smith B, Starling P, Viergutz B, Walsh K, Rathore M, Guzman N, Fridkin S. Prevalence of healthcare-associated infections in acute care hospitals in Jacksonville, Florida. Infect Control Hosp Epidemiol. 2012 Mar;33(3):283-91. doi: 10.1086/664048. Epub 2012 Jan 12.

    PubMed 22314066

  • Chahoud J, Kanafani Z, Kanj SS. Surgical site infections following spine surgery: eliminating the controversies in the diagnosis. Front Med (Lausanne). 2014 Mar 24;1:7. doi: 10.3389/fmed.2014.00007. eCollection 2014.

    PubMed 25705620

  • Silber JS, Anderson DG, Vaccaro AR, Anderson PA, McCormick P; NASS. Management of postprocedural discitis. Spine J. 2002 Jul-Aug;2(4):279-87. doi: 10.1016/s1529-9430(02)00203-6.

    PubMed 14589480

  • Rechtine GR, Bono PL, Cahill D, Bolesta MJ, Chrin AM. Postoperative wound infection after instrumentation of thoracic and lumbar fractures. J Orthop Trauma. 2001 Nov;15(8):566-9. doi: 10.1097/00005131-200111000-00006.

    PubMed 11733673

  • Whitmore RG, Stephen J, Stein SC, Campbell PG, Yadla S, Harrop JS, Sharan AD, Maltenfort MG, Ratliff JK. Patient comorbidities and complications after spinal surgery: a societal-based cost analysis. Spine (Phila Pa 1976). 2012 May 20;37(12):1065-71. doi: 10.1097/BRS.0b013e31823da22d.

    PubMed 22045005

  • Onishi Y, Masuda K, Tozawa K, Karita T. Outcomes of an Intraoperative Povidone-Iodine Irrigation Protocol in Spinal Surgery for Surgical Site Infection Prevention. Clin Spine Surg. 2019 Dec;32(10):E449-E452. doi: 10.1097/BSD.0000000000000908.

    PubMed 31609802

  • De Luna V, Mancini F, De Maio F, Bernardi G, Ippolito E, Caterini R. Intraoperative Disinfection by Pulse Irrigation with Povidone-Iodine Solution in Spine Surgery. Adv Orthop. 2017;2017:7218918. doi: 10.1155/2017/7218918. Epub 2017 Oct 2.

    PubMed 29098088

  • Watanabe M, Sakai D, Matsuyama D, Yamamoto Y, Sato M, Mochida J. Risk factors for surgical site infection following spine surgery: efficacy of intraoperative saline irrigation. J Neurosurg Spine. 2010 May;12(5):540-6. doi: 10.3171/2009.11.SPINE09308.

    PubMed 20433302

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing saline 0.9% and (0.05% chlorhexidine gluconate (CHG) in sterile water) in people with Lumbar Spine Degeneration and Cervical Spine Degeneration, run by University of Missouri-Columbia 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 27 Dec 2022. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Center for Disease Control (CDC)-defined 90-day surgical site infection incidence (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408923, which also lists 8 linked publications.

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 27 Dec 2022.

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