Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Completed · Phase 4

Conditions studied: Surgical Site Infection

In brief

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.

Key facts

Study ID

NCT02527512

Run by

Boston Children's Hospital

People needed

173

Starts

2017-07-13

Expected to finish

2019-07-12

Last updated by the study team

2021-05-10

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 3 to 18 years on day of surgery
• diagnosis of spinal deformity
• undergoing elective posterior spine multi-level instrumentation surgery

You may not qualify if…

• 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.

Where it is running

• Children's Mercy Kansas City — Kansas City, Missouri, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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