NCT02527512

Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-07-13
• Primary completion: 2019-02-01
• Completion: 2019-07-12
• First posted: 2015-08-19
• Last updated: 2021-05-10
• Results posted: 2021-05-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study