The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Attabib, Najmedden, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Najmedden Attabib, Attabib, Najmedden, M.D.
ClinicalTrials.gov Identifier:
NCT01577524
First received: March 30, 2012
Last updated: April 12, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 430
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577524

Contacts
Contact: Heidi Kelly, BN 506-648-6373 heidi.kelly@horizonNB.ca
Contact: Najmedden Attabib, MD 506-648-7160 attabib2002@yahoo.com

Locations
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Heidi Kelly, BN    506-648-6373    heidi.kelly@horizonNB.ca   
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
Study First Received: March 30, 2012
Last Updated: April 12, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Povidone
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014