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

Primary Purpose

Spinal Diseases, Spinal Fusion, Spine Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group A - Pulsed PVP-I Irrigation
Sponsored by
University of Rome Tor Vergata
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Diseases focused on measuring Pulse Irrigation Povidone Iodine Spine Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A - Pulsed PVP-I Irrigation

    Group B - Pulsed Saline Irrigation

    Arm Description

    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 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

    Outcomes

    Primary Outcome Measures

    Number of Participants With surgical site infection
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2017
    Last Updated
    August 14, 2017
    Sponsor
    University of Rome Tor Vergata
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03249363
    Brief Title
    Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
    Official Title
    Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2010 (Actual)
    Primary Completion Date
    January 1, 2012 (Actual)
    Study Completion Date
    January 1, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Rome Tor Vergata

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Diseases, Spinal Fusion, Spine Injury, Infection, Hospital
    Keywords
    Pulse Irrigation Povidone Iodine Spine Surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - Pulsed PVP-I Irrigation
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Group B - Pulsed Saline Irrigation
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Group A - Pulsed PVP-I Irrigation
    Primary Outcome Measure Information:
    Title
    Number of Participants With surgical site infection
    Description
    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)
    Time Frame
    From the surgery to 1 year after

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery

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