The Use of Diluted Povidone Iodine Irrigation in Spine Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Number of post-operative infections diagnosed in both treatment and control groups
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diluted Povidone Iodine Solution
Intervention: Povidone-Iodine (Drug)
Normal Saline Wash
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Najmedden Attabib
Principle Investigator
Attabib, Najmedden, M.D.