CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 173 enrolled
Drug / intervention
Povidone-Iodine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02527512
NCT02527512Phase 4Completed
CompareCT.gov

Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery

Boston Children's Hospital·interventional·Posted Aug 19, 2015·Updated May 10, 2021

In Brief

A Phase 4 clinical trial evaluating Povidone-Iodine and Normal Saline for Surgical Site Infection. Completed, enrolled 173 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Site Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartJul 13, 2017
Primary CompletionFeb 1, 2019
Study CompletionJul 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.9 years ago

Interventions

Povidone-Iodinedrug

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

Normal Salineother

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