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The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

This study has been terminated.
(We had very low recruitment rates that would have resulted in several years being added to the study to achieve an appropriate sample size.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577524
First Posted: April 16, 2012
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Najmedden Attabib, Attabib, Najmedden, M.D.
  Purpose
The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections.

Condition Intervention Phase
Surgical Site Infection Drug: Povidone-Iodine Drug: Saline Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Resource links provided by NLM:


Further study details as provided by Dr. Najmedden Attabib, Attabib, Najmedden, M.D.:

Primary Outcome Measures:
  • Number of post-operative infections diagnosed in both treatment and control groups [ Time Frame: Twelve months post operation ]

    The Centers for Disease Control (CDC)definition of surgical site infections (SSI)will be used for this study.This definition addresses both superficial and deep surgical site infections.

    Outcome will be determined by the number of superficial, deep, and total (superficial plus deep) wound infections for each group.



Enrollment: 58
Study Start Date: January 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diluted Povidone Iodine Solution Drug: Povidone-Iodine
Subjects in the treatment group will receive 3.5% diluted Povidone Iodine solution in the surgical incision in a quantity sufficient to fill the wound to the level of the skin. The Povidone Iodine solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with normal saline solution.
Other Name: Betadine
Placebo Comparator: Normal Saline Wash Drug: Saline
Subjects in the Placebo Comparator group will receive normal saline solution in a quantity sufficient to fill the wound to the level of the skin. The saline solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with additional saline solution to replicate the saline wash procedure followed in the Treatment group.

Detailed Description:

Post-operative infections in spine surgery have been extensively investigated in the literature. These investigations focus on the efficacy of using peri-operative antibiotics, Povidone Iodine skin preparations, the effects of shaving around the surgical sit, and the use of intra-operative diluted Povidone Iodine wound irrigation in preventing post-operative infections.

Povidone-iodine is a complex of polyvinyl pyrrolidine and tri-iodine ions widely used as an antiseptic agent. It has bactericidal activity against a wide spectrum of pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The safety of its use intra-operatively has been evaluated in animal studies and also supported through Randomized Controlled Trials in spinal surgery and in other surgical subspecialties.

The purpose of this study is to evaluate the efficacy of the intra-operative use of diluted Povidone Iodine solution in reducing post-operative infections when used for irrigating surgical incisions during spinal surgery compared with 0.9% Sodium Chloride Irrigation Solution (i.e. normal saline solution).

The primary outcome measure will be seen as a reduction in the number of post-operative infections. As a result and although not directly measured, it is suspected that a reduction in post-operative infections may result in quicker healing with fewer complications and pain.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18-75
  • Undergoing posterior surgical spinal procedure for degenerative spine disease, extra-dural tumors, trauma, or spinal deformity
  • No obvious potential infective focus
  • Patient willing to enroll

Exclusion Criteria:

  • Age <18 or >75
  • Identified infective focus in the body, including furuncles,or acne at surgical incision site
  • Patient with discitis or spinal osteomyelitis
  • Dural tear
  • Potential use of Bone Morphogenic Protein (BMP)
  • Iodine hypersensitivity
  • Out of province patients due to difficulty in arranging follow up visits
  • Minimal invasive spine surgical procedure (MISS) due to difficulty of having diluted Betadine solution contact soft tissue with the use if MISS retractors
  • Pregnancy
  • Inability to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577524


Locations
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Sponsors and Collaborators
Attabib, Najmedden, M.D.
Investigators
Principal Investigator: Najmedden Attabib, MD Neurosurgery Department, Saint John Regional Hospital
  More Information

Publications:

Responsible Party: Dr. Najmedden Attabib, Principle Investigator, Attabib, Najmedden, M.D.
ClinicalTrials.gov Identifier: NCT01577524     History of Changes
Other Study ID Numbers: 2009-1350
First Submitted: March 30, 2012
First Posted: April 16, 2012
Last Update Posted: July 14, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes