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

Spinal Fusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249363
• Other study ID #: URome
• Status: Completed
• Phase: N/A
• First received: July 5, 2017
• Last updated: August 14, 2017
• Start date: January 1, 2010
• Est. completion date: January 1, 2012

Study information

• Verified date: August 2017
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2012
• Est. primary completion date: January 1, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Infection, Hospital
• Spinal Diseases
• Spinal Fusion
• Spinal Injuries
• Spine Injury

Intervention

Procedure:
• Group A - Pulsed PVP-I Irrigation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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