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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03249363

Enrollment

Registered

2017-08-15

Start date

2010-01-01

Completion date

2012-01-01

Last updated

2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pulse Irrigation Povidone Iodine Spine Surgery

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

Detailed 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.

Interventions

PROCEDUREGroup A - Pulsed PVP-I Irrigation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With surgical site infection	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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026