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

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

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Key information

Conditions

Spinal Diseases Back Injuries Bone Diseases Cross Infection Disease Attributes Iatrogenic Disease Infection, Hospital Infections Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Fusion Spinal Injuries Spine Injury Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A - Pulsed PVP-I Irrigation

Procedure

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Aug 15, 2017
Registry last updated: Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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