The Use of Diluted Povidone Iodine Irrigation in Spine Surgery
Recruitment status was Recruiting
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.
|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|
- 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.
|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)|
|Active Comparator: Diluted Povidone Iodine Solution||
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||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577524
|Contact: Heidi Kelly, BN||506-648-6373||heidi.kelly@horizonNB.ca|
|Contact: Najmedden Attabib, MDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Najmedden Attabib, MD||Neurosurgery Department, Saint John Regional Hospital|