Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Phase 4

Completed

• Conditions: Surgical Site Infection
• Interventions: Other: Normal Saline; Drug: Povidone-Iodine

• Registration Number: NCT02527512
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Study Start: 2017-07-13
• Primary Completion: 2019-02-01
• Study Completion: 2019-07-12
• Results First Submitted: 2020-08-11
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-15
• Last Update Submitted: 2021-04-15
• Results First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Sterile sodium chloride (NaCl) solution
Povidone-Iodine	Povidone-Iodine	0.35% povidone-iodine ("Betadine")

Primary Outcome Measures

Name	Time	Method
Culture Positivity	Cultures taken before and after irrigation during surgery	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.

Secondary Outcome Measures

Name	Time	Method
Risk Groups	Cultures taken before and after irrigation during surgery	Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity

Trial Locations

Locations (2)

Children's Mercy Kansas City; 🇺🇸 Kansas City, Missouri, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States