Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
Akron Children's Hospital
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.
Description
This is a prospective, one site, randomized controlled trial. The goal of this project is to evaluate the efficacy of subdermal 10% povidone-iodine at reducing bacterial contamination from the subdermal layer of skin during posterior spinal fusion. The primary outcome of this study will be incidence of positive bacterial growth in several layers of the surgical wound. Secondary outcomes will be complications, including allergic reactions, contact dermatitis, surgical site infection and wound complications. Finally, patient and surgical variables that can effect microbial growth will be observe…
Eligibility
- Age range
- Up to 26 years
- Sex
- All
- Healthy volunteers
- No
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
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.
Location
- Akron Children's HospitalAkron, Ohio