Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:3 - 18
Updated:10/3/2018
Start Date:July 13, 2017
End Date:September 2019

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Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion 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 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.

Inclusion Criteria:

1. Age 3 to 18 years on day of surgery

2. diagnosis of spinal deformity

3. undergoing elective posterior spine multi-level instrumentation surgery

Exclusion Criteria:

1. Documented renal failure

2. documented allergy to iodine or shellfish

3. previous spine fusion surgery

4. undergoing elective posterior spine single-level instrumentation surgery

5. undergoing anterior spine multi-level instrumentation surgery

6. current antibiotic use.
We found this trial at
2
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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2401 Gillham Road
Kansas City, Missouri 64108
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Kansas City, MO
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