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NCT02527512 · ClinicalTrials.gov registry record · Phase 4
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 173
- Enrollment target
NCT02527512: Completed Phase 4 study, sponsored by Boston Children's Hospital.
NCT02527512 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 173 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02527512, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 173 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Normal Saline
- DRUG Povidone-Iodine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2017-07-13 |
| Est. Completion | 2019-07-12 |
| Phase | Phase 4 |
What the finished NCT02527512 record still lists
NCT02527512 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02527512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02527512 about?
NCT02527512 is a clinical study titled "Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery". 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...
What is the current status of trial NCT02527512?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 173 participants. The study started on 2017-07-13. Estimated completion is 2019-07-12.
What interventions are being tested in trial NCT02527512?
The interventions under investigation include: Normal Saline (OTHER), Povidone-Iodine (DRUG).
Who is sponsoring clinical trial NCT02527512?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02527512's enrollment target sits among peer trials
173 481st of 2000 higher than 1,520 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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