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

August 14, 2017 updated by: Gabriele Bernardi, University of Rome Tor Vergata
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Group A - Pulsed PVP-I Irrigation
Active Comparator: Group B - Pulsed Saline 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
Procedure: Group A - Pulsed PVP-I Irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With surgical site infection
Time Frame: 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)
From the surgery to 1 year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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