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It was determined not to be feasible at our site at this time.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Patients in this group will be given the placebo (sterile saline). |
|
| Irrisept | Active Comparator | Patients in this group will be given the study drug (Irrisept). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline 0.9% | Drug | Control group will get normal saline for irrigation throughout the case. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | Comparing post-operative wound healing incidence between groups for 90 days post-operative using t-Test | 90 days after surgery |
| Wound complications | Comparing post-operative wound complications incidence between groups for 90 days post-operative using chi-square test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Kim Moore, MD | University of Missouri - Missouri Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22314066 | Background | 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. | |
| 25705620 |
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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.
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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.
| (0.05% chlorhexidine gluconate (CHG) in sterile water) | Drug | Intervention group will get Irrisept irrigation (0.05% CHG in sterile water) throughout the case. |
|
|
| 90 days after surgery |
| Background |
| 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. |
| 14589480 | Background | 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. |
| 11733673 | Background | 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. |
| 22045005 | Background | 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. |
| 31609802 | Background | 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. |
| 29098088 | Background | 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. |
| 20433302 | Background | 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. |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C010882 | chlorhexidine gluconate |
| D002864 | Chromogranins |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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