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

Not Applicable

Completed

• Conditions: Infection, Hospital; Spinal Fusion; Spine Injury; Spinal Diseases
• Interventions: Procedure: Group A - Pulsed PVP-I Irrigation

• Registration Number: NCT03249363
• Lead Sponsor: University of Rome Tor Vergata

Brief 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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2012-01-01
• Study Completion: 2012-01-01
• Study First Submitted: 2017-07-05
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-09
• Last Update Submitted: 2017-08-14
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Male and Female
• Patients candidated to spinal surgery for spinal surgery
• Primary spinal surgery procedure

Exclusion Criteria

• Clinical signs of infection before surgery
• Previous spinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - Pulsed PVP-I Irrigation	Group A - Pulsed PVP-I Irrigation	Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with Povidone-Iodine (PVP-I) diluted to a 3% concentration (30g/l) in 2 l of saline performed before applying the bone graft
Group B - Pulsed Saline Irrigation	Group A - Pulsed PVP-I Irrigation	Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with only 2 litres of saline solution (without povidone Iodine) performed before applying the bone graft

Primary Outcome Measures

Name	Time	Method
Number of Participants With surgical site infection	From the surgery to 1 year after	Comparison of the results obtained from microbiological bacterial cultures of samples harvested during complex spine surgery in two groups of patients treated intraoperatively with pulsatile irrigation with diluted PVP-I (group A) or pulsatile irrigation with saline solution (group B)