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Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

NCT02527512 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2021-05-10

Study results available
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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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Povidone-Iodine

Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine

OTHER

Normal Saline

Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter

Sponsors & Collaborators

Principal Investigators

  • Michael Glotzbecker, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-13
Primary Completion
2019-02-01
Completion
2019-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527512 on ClinicalTrials.gov