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

University of Rome Tor Vergata

Status: Completed

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

Treatments: Procedure: Group A - Pulsed PVP-I Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03249363

URome

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Group A - Pulsed PVP-I Irrigation

Experimental group

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

Treatment:

Procedure: Group A - Pulsed PVP-I Irrigation

Group B - Pulsed Saline Irrigation

Active Comparator group

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

Treatment:

Procedure: Group A - Pulsed PVP-I Irrigation