The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Attabib, Najmedden, M.D.

Status and phase: Terminated; Phase 2

Conditions: Surgical Site Infection

Treatments: Drug: Saline; Drug: Povidone-Iodine

Study type: Interventional

Identifiers

NCT01577524

2009-1350

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups, including a placebo group

Diluted Povidone Iodine Solution

Active Comparator group

Treatment:

Drug: Povidone-Iodine

Normal Saline Wash

Placebo Comparator group

Treatment:

Drug: Saline