A Phase 2 interventional study of Povidone-Iodine and Saline in Surgical Site Infection, sponsored by Attabib, Najmedden, M.D.. Terminated at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-07-14.
Sponsored by Attabib, Najmedden, M.D. · Phase 2, Interventional, and Prevention
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.
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's enrollment of 58 is below the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →This is the only study on the registry with Attabib, Najmedden, M.D. as lead sponsor.
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Exclusion Criteria:
Drug: Povidone-Iodine
Drug: Saline
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.
Also known as: Betadine
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.
Number of post-operative infections diagnosed in both treatment and control groups
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.
Time frame: Twelve months post operation
This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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