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

NCT ID: NCT05408923

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2026-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Lumbar Spine Degeneration Cervical Spine Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Irrisept can be differentiated visually from normal saline. Patients will be informed in the consent that they will be blinded to the treatment they are randomized to throughout the study.

Study Groups

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Placebo Group

Patients in this group will be given the placebo (sterile saline).

Group Type PLACEBO_COMPARATOR

saline 0.9%

Intervention Type DRUG

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

Irrisept

Patients in this group will be given the study drug (Irrisept).

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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saline 0.9%

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Other Intervention Names

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sterile saline Irrisept

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Don Moore, MD

PROF, AST CLINICAL DEPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Don Kim Moore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri - Missouri Orthopaedic Institute

Locations

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Missouri Orthopaedic Institute

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22314066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25705620 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14589480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11733673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22045005 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31609802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29098088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20433302 (View on PubMed)

Other Identifiers

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2083162

Identifier Type: -

Identifier Source: org_study_id