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

NCT03249363 | Completed

• 1 other identifier: URome
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

Pulse Irrigation Povidone Iodine Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A - Pulsed PVP-I Irrigation

EXPERIMENTAL

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

Group B - Pulsed Saline Irrigation

ACTIVE COMPARATOR

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

Interventions

Group A - Pulsed PVP-I Irrigation PROCEDURE

Group A - Pulsed PVP-I Irrigation; Group B - Pulsed Saline Irrigation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female
• Patients candidated to spinal surgery for spinal surgery
• Primary spinal surgery procedure

You may not qualify if:

• Clinical signs of infection before surgery
• Previous spinal surgery

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Related Publications (36)

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• De Luna V, Mancini F, De Maio F, Bernardi G, Ippolito E, Caterini R. Intraoperative Disinfection by Pulse Irrigation with Povidone-Iodine Solution in Spine Surgery. Adv Orthop. 2017;2017:7218918. doi: 10.1155/2017/7218918. Epub 2017 Oct 2.

  PMID: 29098088 DERIVED

MeSH Terms

Conditions

Spinal Diseases; Spinal Injuries; Cross Infection

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Back Injuries; Wounds and Injuries; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 15, 2017
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 17, 2017

Record last verified: 2017-08