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
About this trial
This is an interventional prevention trial for Spinal Diseases focused on measuring Pulse Irrigation Povidone Iodine Spine Surgery
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
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
NCT ID
NCT03249363
First Posted
July 5, 2017
Last Updated
August 14, 2017
Sponsor
University of Rome Tor Vergata
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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