Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02527512
Recruitment Status : Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Glotzbecker, 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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Povidone-Iodine Other: Normal Saline Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery
Actual Study Start Date : July 13, 2017
Actual Primary Completion Date : February 1, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Povidone-Iodine
0.35% povidone-iodine ("Betadine")
Drug: Povidone-Iodine
Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
Other Name: Betadine

Active Comparator: Normal Saline
Sterile sodium chloride (NaCl) solution
Other: Normal Saline
Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Other Name: NSS, NS or N/S




Primary Outcome Measures :
  1. Establish safety of use of dilute povidone-iodine irrigation [ Time Frame: Preoperative to Postoperative Visit (30 or 90 day post surgery) ]
    Number of patients with an initial positive bacterial culture prior to irrigation as assessed by identification of infection at 30 or 90 day


Secondary Outcome Measures :
  1. Establish population (ie idiopathic vs neuromuscular) specific differences in tissue colonization prior to closure [ Time Frame: Surgery ]
    Evaluate bacteriology of tissue contamination as assessed by identification of infection by population status

  2. Establish estimates for the effect that povidone-iodine/saline have on reducing [ Time Frame: Surgery ]
    Evaluate bacteriology of tissue contamination as assessed by identification of infection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02527512


Locations
Layout table for location information
United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64114
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Layout table for investigator information
Principal Investigator: Michael Glotzbecker, MD Boston Children’s Hospital

Publications:
Layout table for additonal information
Responsible Party: Michael Glotzbecker, Assistant Professor, Orthopaedic Surgery, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02527512     History of Changes
Other Study ID Numbers: IRB-P00015085
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Glotzbecker, Boston Children’s Hospital:
Scoliosis
Spine fusion
0.35% povidone-iodine
Additional relevant MeSH terms:
Layout table for MeSH terms
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes