Trial | NCT01577524  Report issue

Official Title

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    58
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.
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.
Study Started
Jan 31
2012
Primary Completion
Jun 30
2016
Study Completion
Jun 30
2016
Last Update
Jul 14
2016
Estimate

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 names: Betadine

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.

Diluted Povidone Iodine Solution Active Comparator

Normal Saline Wash Placebo Comparator

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
No Results Posted