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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine | Active Comparator | 0.35% povidone-iodine ("Betadine") |
|
| Normal Saline | Active Comparator | Sterile sodium chloride (NaCl) solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine | Drug | Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Glotzbecker, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Kansas City | Missouri | 64114 | United States | ||
| The Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1890121 | Background | Dietz FR, Koontz FP, Found EM, Marsh JL. The importance of positive bacterial cultures of specimens obtained during clean orthopaedic operations. J Bone Joint Surg Am. 1991 Sep;73(8):1200-7. | |
| 23370682 | Background | Nandyala SV, Schwend RM. Prevalence of intraoperative tissue bacterial contamination in posterior pediatric spinal deformity surgery. Spine (Phila Pa 1976). 2013 Apr 15;38(8):E482-6. doi: 10.1097/BRS.0b013e3182893be1. |
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There were 6 patients that were ineligible after enrollment and were excluded prior to group assignment. The reasons included: fused fewer levels than planned(< 6 levels), surgeon forgot to take swap samples, excessive bleeding and transfusion, put on antibiotic after enrollment and one family asked to be removed after enrollment. Thus, a total of 167 subjects were assigned to treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Povidone-Iodine | 0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine |
| FG001 | Normal Saline | Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-Iodine | 0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine |
| BG001 | Normal Saline | Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Cultures taken before and after irrigation during surgery |
|
Up to 90 days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-Iodine | 0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine |
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While this study was underpowered to detect a statistically significant difference between the study arms, a difference may not exist. If a difference does exist, it would require a large cohort to be statistically significant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Hutchinson, Clinical Research Manager | Boston Children's Hospital | 6179191632 | lauren.hutchinson@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 16, 2017 | Sep 14, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2017 | Sep 14, 2020 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Normal Saline | Other | Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter |
|
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 16133077 | Background | Chang FY, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Can povidone-iodine solution be used safely in a spinal surgery? Eur Spine J. 2006 Jun;15(6):1005-14. doi: 10.1007/s00586-005-0975-6. Epub 2005 Aug 20. |
| 16094267 | Background | Cheng MT, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Efficacy of dilute betadine solution irrigation in the prevention of postoperative infection of spinal surgery. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1689-93. doi: 10.1097/01.brs.0000171907.60775.85. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ASA | The American Society of Anesthesiologists' Classification of Physical Health Classification was used to asses perioperative risks and patients that were classified as ASA I-IV were included for the study: ASA I- A normal healthy person ASA II- Mild systemic diseases ASA III- Severe systemic disease with substantive functional limitations ASA IV- Severe systemic disease that is a constant threat to life ASA I group is predictive of better outcomes while ASA IV is associated with least favorable treatment outcome. | Count of Participants | Participants |
|
| Risk Group | Count of Participants | Participants |
|
|
|
| Secondary | Risk Groups | Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity | Posted | Count of Participants | Participants | Cultures taken before and after irrigation during surgery |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Normal Saline | Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter | 0 | 76 | 0 | 76 | 0 | 76 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| negative |
|
| post-irrigation |
|