Phase 4
Completed N=167
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Source: ClinicalTrials.gov NCT02527512 ↗Enrolled (actual)
167
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Culture Positivity — 14; 13; 63; 63 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Culture Positivity |
14; 13; 63; 63; 12; 14 | — |
| SECONDARY Risk Groups |
2; 3; 12; 10; 16; 16 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02527512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.