Clinical trial NCT03249363: Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
Official title: Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Diseases
Spinal Fusion
Spine Injury
Infection, Hospital
Keywords: Pulse Irrigation Povidone Iodine Spine Surgery
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With surgical site infection
timeFrame: From the surgery to 1 year after
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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