Skip to main content
OpenTrials
Completed

NCT Number: NCT02527512

Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Site Infection Bone Diseases Infections Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Scoliosis Spinal Curvatures Spinal Diseases Surgical Wound Infection Wound Infection

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Mercy Kansas City, Kansas City, Missouri, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Povidone-Iodine

Drug

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

Other names: Betadine

Normal Saline

Other

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

Other names: NSS, NS or N/S

Primary outcomes

  1. Culture Positivity

    Time frame: 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 outcomes

  1. Risk Groups

    Time frame: Cultures taken before and after irrigation during surgery

    Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.