Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

NCT02527512 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB-P00015085
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Site Infection

Keywords

Scoliosis; Spine fusion; 0.35% povidone-iodine

Outcome Measures

Primary Outcomes (1)

• 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.

  Cultures taken before and after irrigation during surgery

Secondary Outcomes (1)

• Risk Groups

  Cultures taken before and after irrigation during surgery

Study Arms (2)

Povidone-Iodine

ACTIVE COMPARATOR

0.35% povidone-iodine ("Betadine")

Drug: Povidone-Iodine

Normal Saline

ACTIVE COMPARATOR

Sterile sodium chloride (NaCl) solution

Other: Normal Saline

Interventions

Povidone-Iodine DRUG

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

Also known as: Betadine

Povidone-Iodine

Normal Saline OTHER

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

Also known as: NSS, NS or N/S

Normal Saline

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Children's Mercy Kansas City

Kansas City, Missouri, 64114, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• 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.

  PMID: 1890121 BACKGROUND

• 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.

  PMID: 23370682 BACKGROUND

• 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.

  PMID: 16133077 BACKGROUND

• 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.

  PMID: 16094267 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Scoliosis

Interventions

Povidone-Iodine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

While this study was underpowered to detect a statistically significant difference between the study arms, a difference may not exist. If a difference does exist, it would require a large cohort to be statistically significant.

Results Point of Contact

• Title: Lauren Hutchinson, Clinical Research Manager
• Organization: Boston Children's Hospital

lauren.hutchinson@childrens.harvard.edu

6179191632

Study Officials

• Michael Glotzbecker, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopaedic Surgery

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 19, 2015
• Study Start: July 13, 2017
• Primary Completion: February 1, 2019
• Study Completion: July 12, 2019
• Last Updated: May 10, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)