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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Spinal Diseases, Spinal Fusion, Spine Injury, Infection, Hospital

Intervention / Treatment
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* Procedure: Group A - Pulsed PVP-I Irrigation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Pulsed PVP-I Irrigation<br>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<br> <br> |
| Active Comparator: Group B - Pulsed Saline Irrigation<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | From the surgery to 1 year after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulse Irrigation Povidone Iodine Spine Surgery