Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Study Overview
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Brief Summary
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This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.

Detailed Description
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Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.

Official Title
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Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Povidone-Iodine
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3 to 18 years on day of surgery diagnosis of spinal deformity undergoing elective posterior spine multi-level instrumentation surgery Exclusion Criteria: Documented renal failure documented allergy to iodine or shellfish previous spine fusion surgery undergoing elective posterior spine single-level instrumentation surgery undergoing anterior spine multi-level instrumentation surgery current antibiotic use.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Povidone-Iodine<br>0.35% povidone-iodine (Betadine) | Drug: Povidone-Iodine<br>* Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine<br>* Other names: Betadine;|
| Active Comparator: Normal Saline<br>Sterile sodium chloride (NaCl) solution | Other: Normal Saline<br>* Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter<br>* Other names: NSS, NS or N/S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture Positivity | Assess feasibility of a larger randomized controlled trial using significance of differences in the bacteriology and contamination rates of both treatment arms. Also measured baseline tissue colonization rates. | Cultures taken before and after irrigation during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Groups | Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity | Cultures taken before and after irrigation during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scoliosis, Spine fusion, 0.35% povidone-iodine