The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Attabib, Najmedden, M.D.
• Treatments: Cadexomer iodine; Iodine; Povidone; Povidone-Iodine

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