NCT03249363

Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds

Detailed description

The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds were irrigated with normal saline solution thorough a bulb syringe. In both subgroup specimens for bacterial culture were harvested by swabs from surgical site before and after irrigation of the wounds.

Conditions

• Spinal Diseases
• Spinal Fusion
• Spine Injury
• Infection, Hospital

Interventions

Type	Name	Description
PROCEDURE	Group A - Pulsed PVP-I Irrigation

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2017-08-15
• Last updated: 2017-08-17