Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02527512
• Collaborator: (none)
• Enrollment: 173
• Locations: 2
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 86.5
• Patients Per Site Per Month: 3.6

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 173 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: Jul 13, 2017
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Jul 12, 2019

Arms and Interventions

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 Names: 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 Names: NSS, NS or N/S

Outcome Measures

Primary Outcome Measures

1. 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

1. Risk Groups [Cultures taken before and after irrigation during surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Mercy Kansas City	Kansas City	Missouri	United States	64114
2	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

• Principal Investigator: Michael Glotzbecker, MD, Boston Children's Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 16, 2017
• Informed Consent Form - Oct 31, 2017

More Information

Publications

• 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. Epub 2005 Aug 20.
• 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.
• 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.
• 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.

• Responsible Party: Michael Glotzbecker, Assistant Professor, Orthopaedic Surgery, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02527512
• Other Study ID Numbers: IRB-P00015085
• First Posted: Aug 19, 2015
• Last Update Posted: May 10, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael Glotzbecker, Assistant Professor, Orthopaedic Surgery, Boston Children's Hospital: Scoliosis; Spine fusion; 0.35% povidone-iodine
• Additional relevant MeSH terms: Surgical Wound Infection; Povidone-Iodine; Povidone

Study Results

Participant Flow

Pre-assignment Detail	There were 6 patients that were ineligible after enrollment and were excluded prior to group assignment. The reasons included: fused fewer levels than planned(< 6 levels), surgeon forgot to take swap samples, excessive bleeding and transfusion, put on antibiotic after enrollment and one family asked to be removed after enrollment. Thus, a total of 167 subjects were assigned to treatment groups.

Arm/Group Title	Povidone-Iodine	Normal Saline
Arm/Group Description	0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine	Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Period Title: Overall Study
STARTED	85	82
COMPLETED	77	76
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	Povidone-Iodine	Normal Saline	Total
Arm/Group Description	0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine	Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter	Total of all reporting groups
Overall Participants	77	76	153
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.6 (2.39)	14.8 (2.04)	14.7 (2.28)
Sex: Female, Male (Count of Participants)
Female	62 80.5%	60 78.9%	122 79.7%
Male	15 19.5%	16 21.1%	31 20.3%
Race/Ethnicity, Customized (Count of Participants)
White	59 76.6%	49 64.5%	108 70.6%
Black/ African American	4 5.2%	5 6.6%	9 5.9%
Asian	1 1.3%	2 2.6%	3 2%
American Indian/ Alakan Naitive	0 0%	0 0%	0 0%
Native Hawaiian/ Pacific Islander	0 0%	0 0%	0 0%
Unknown/ Refused/ Missing	13 16.9%	20 26.3%	33 21.6%
ASA (Count of Participants)
1	23 29.9%	20 26.3%	43 28.1%
2	34 44.2%	34 44.7%	68 44.4%
3	19 24.7%	22 28.9%	41 26.8%
4	1 1.3%	0 0%	1 0.7%
Risk Group (Count of Participants)
Low risk (idiopathic)	59 76.6%	57 75%	116 75.8%
High risk (other etiologies)	18 23.4%	19 25%	37 24.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Povidone-Iodine	Normal Saline
Arm/Group Description	0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine	Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
Measure Participants	77	76
bacteria present	14 18.2%	13 17.1%
bacteria absent	63 81.8%	63 82.9%
bacteria present	12 15.6%	14 18.4%
bacteria absent	65 84.4%	62 81.6%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Povidone-iodine	High Risk Saline	Low Risk Povidone-iodine	Low Risk Saline
Arm/Group Description	congenital, neuromuscular, and syndromic deformities	congenital, neuromuscular, and syndromic deformities	idiopathic deformities	idiopathic deformities
Measure Participants	18	19	59	57
positive	2 2.6%	3 3.9%	12 7.8%	10 NaN
negative	16 20.8%	16 21.1%	47 30.7%	47 NaN
positive	5 6.5%	4 5.3%	7 4.6%	10 NaN
negative	13 16.9%	15 19.7%	52 34%	47 NaN

Adverse Events

Time Frame	Up to 90 days postoperatively
Arm/Group Title	Povidone-Iodine		Normal Saline
Arm/Group Description	0.35% povidone-iodine ("Betadine") Povidone-Iodine: Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine		Sterile sodium chloride (NaCl) solution Normal Saline: Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
All Cause Mortality
	Povidone-Iodine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/76 (0%)
Serious Adverse Events
	Povidone-Iodine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/76 (0%)
Other (Not Including Serious) Adverse Events
	Povidone-Iodine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/76 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.