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

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ClinicalTrials.gov Identifier: NCT03249363
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriele Bernardi, 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

Condition or disease Intervention/treatment Phase
Spinal Diseases Spinal Fusion Spine Injury Infection, Hospital Procedure: Group A - Pulsed PVP-I Irrigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : January 1, 2012
Actual Study Completion Date : January 1, 2012


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



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabriele Bernardi, MD, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT03249363    
Other Study ID Numbers: URome
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriele Bernardi, University of Rome Tor Vergata:
Pulse Irrigation Povidone Iodine Spine Surgery
Additional relevant MeSH terms:
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Cross Infection
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes