Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-13

Study Completion Date

2019-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Povidone-Iodine

0.35% povidone-iodine ("Betadine")

Group Type ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type DRUG

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

Normal Saline

Sterile sodium chloride (NaCl) solution

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Interventions

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Povidone-Iodine

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

Intervention Type DRUG

Normal Saline

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

Intervention Type OTHER

Other Intervention Names

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Betadine NSS, NS or N/S

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes