Phase 4 N=167 Randomized Single-blind Prevention

Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Surgical Site Infection

Bottom Line

View on ClinicalTrials.gov: NCT02527512 ↗

Enrolled (actual)

167

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Culture Positivity — 14; 13; 63; 63 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Povidone-Iodine (Drug); Normal Saline (Other)
Age: Pediatric, Adult · 3+ yrs
Sex: All
Sponsor: Boston Children's Hospital
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Culture Positivity	14; 13; 63; 63; 12; 14	—
SECONDARY Risk Groups	2; 3; 12; 10; 16; 16	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02527512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.