Using Betadine to Prevent Infections in Spinal Fusion Surgery
Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
This study is testing if using Betadine during spinal fusion surgery can help prevent infections in patients with scoliosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 26 Years |
| Sex | All |
| Sponsor | Akron Children's Hospital Academic / other |
| Locations | 1 site (Akron, Ohio) |
| Trial ID | NCT06744907 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of subdermal 10% povidone-iodine in reducing bacterial contamination during posterior spinal fusion surgeries in patients with scoliosis. It is a prospective, one-site, randomized controlled trial where participants will be assigned to either the povidone-iodine group or a control group. The primary outcome will measure the incidence of positive bacterial growth in the surgical wound, while secondary outcomes will assess complications such as allergic reactions and surgical site infections. The study will also observe various patient and surgical factors that may influence microbial growth.
Who should consider this trial
Good fit: Ideal candidates are males and females undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine.
Not a fit: Patients who have had prior spinal surgery or have contraindications to povidone-iodine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of infections following spinal fusion surgeries.
How similar studies have performed: Other studies have shown promising results with povidone-iodine in surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Males and females * Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine * English Speaking Exclusion Criteria * Patients who have undergone prior spinal surgery * Undergoing procedures other than primary posterior spinal fusion of the thoracic and/or lumbar spine (cervical fusion, anterior surgery, growth-friendly instrumentation) * Any contraindication to povidone-iodine, including pregnancy, allergy, or prior treatment with radioiodine
Where this trial is running
Akron, Ohio
- Akron Children's Hospital — Akron, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Alexandria Rundell, BS
- Email: arundell@akronchildrens.org
- Phone: 330-543-3193
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.