RecruitingPhase 4NCT06744907

Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion


Sponsor

Akron Children's Hospital

Enrollment

60 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal fusion.


Eligibility

Max Age: 26 Years

Inclusion Criteria3

  • Males and females
  • Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
  • English Speaking

Exclusion Criteria3

  • 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

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Interventions

BIOLOGICAL10% Povidone-Iodine Arm

A second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision.

PROCEDURESaline Arm

An application of saline in the subdermal layer after making an incision.


Locations(1)

Akron Children's Hospital

Akron, Ohio, United States

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NCT06744907


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