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Search / Trial NCT06744907

Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

Launched by AKRON CHILDREN'S HOSPITAL · Dec 16, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Spinal Fusion Lumbar Spine Thoracic Spine Subdermal Betadine Microbacterial Bioburden

ClinConnect Summary

This clinical trial is studying whether a special solution called povidone-iodine, commonly known as Betadine, can help prevent infections in patients undergoing spinal fusion surgery for scoliosis. During this procedure, a surgeon connects the bones in the spine to help stabilize it, and it's important to keep the surgical area free of bacteria that could cause infections. The researchers want to see if applying this solution under the skin can improve safety and outcomes for patients.

To participate in this study, you need to be an English-speaking male or female who is having a primary spinal fusion surgery on either the upper (thoracic) or lower (lumbar) spine. Unfortunately, if you’ve had previous spinal surgery or are having a different type of spine procedure, you won’t be eligible. Participants will be monitored throughout the trial to see how well the povidone-iodine works in preventing infections. If you're considering joining this study, it’s essential to know about any allergies or medical conditions that might affect your ability to use this solution. Overall, this trial aims to enhance safety for patients like you during spinal surgeries.

Gender

ALL

Eligibility 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

About Akron Children's Hospital

Akron Children's Hospital is a leading pediatric healthcare institution dedicated to advancing the health and well-being of children through innovative clinical research and trials. With a commitment to excellence in patient care, the hospital leverages its expertise to develop and evaluate new therapies and interventions that address the unique medical needs of children. By fostering collaborations with academic institutions and industry partners, Akron Children's Hospital aims to translate research findings into practical applications, ultimately enhancing treatment options and outcomes for pediatric patients.

Locations

Akron, Ohio, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported