Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Boston Children's Hospital

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: Povidone-Iodine; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02527512

IRB-P00015085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 173 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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173 participants in 2 patient groups

Povidone-Iodine

Active Comparator group

Description:

0.35% povidone-iodine ("Betadine")

Treatment:

Drug: Povidone-Iodine

Normal Saline

Active Comparator group

Description:

Sterile sodium chloride (NaCl) solution

Treatment:

Other: Normal Saline