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Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Povidone-Iodine
Normal Saline
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Scoliosis, Spine fusion, 0.35% povidone-iodine

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Mercy Kansas City
  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Povidone-Iodine

Normal Saline

Arm Description

0.35% povidone-iodine ("Betadine")

Sterile sodium chloride (NaCl) solution

Outcomes

Primary Outcome Measures

Culture Positivity
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

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

Full Information

First Posted
August 7, 2015
Last Updated
April 15, 2021
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02527512
Brief Title
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
Official Title
Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Scoliosis, Spine fusion, 0.35% povidone-iodine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Povidone-Iodine
Arm Type
Active Comparator
Arm Description
0.35% povidone-iodine ("Betadine")
Arm Title
Normal Saline
Arm Type
Active Comparator
Arm Description
Sterile sodium chloride (NaCl) solution
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Betadine
Intervention Description
Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
NSS, NS or N/S
Intervention Description
Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Primary Outcome Measure Information:
Title
Culture Positivity
Description
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.
Time Frame
Cultures taken before and after irrigation during surgery
Secondary Outcome Measure Information:
Title
Risk Groups
Description
Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity
Time Frame
Cultures taken before and after irrigation during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Glotzbecker, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1890121
Citation
Dietz FR, Koontz FP, Found EM, Marsh JL. The importance of positive bacterial cultures of specimens obtained during clean orthopaedic operations. J Bone Joint Surg Am. 1991 Sep;73(8):1200-7.
Results Reference
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PubMed Identifier
23370682
Citation
Nandyala SV, Schwend RM. Prevalence of intraoperative tissue bacterial contamination in posterior pediatric spinal deformity surgery. Spine (Phila Pa 1976). 2013 Apr 15;38(8):E482-6. doi: 10.1097/BRS.0b013e3182893be1.
Results Reference
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PubMed Identifier
16133077
Citation
Chang FY, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Can povidone-iodine solution be used safely in a spinal surgery? Eur Spine J. 2006 Jun;15(6):1005-14. doi: 10.1007/s00586-005-0975-6. Epub 2005 Aug 20.
Results Reference
background
PubMed Identifier
16094267
Citation
Cheng MT, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Efficacy of dilute betadine solution irrigation in the prevention of postoperative infection of spinal surgery. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1689-93. doi: 10.1097/01.brs.0000171907.60775.85.
Results Reference
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Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

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