Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 26
Healthy Volunteers: f
View:
• Males and females
• Undergoing primary posterior spinal fusion of the thoracic and/or lumbar spine
• English Speaking
Locations
United States
Ohio
Akron Children's Hospital
RECRUITING
Akron
Contact Information
Primary
Alexandria Rundell, BS
arundell@akronchildrens.org
330-543-3193
Backup
Lorena Floccari, MD
lfloccari@akronchildrens.org
330-543-3193
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2026-11
Participants
Target number of participants: 60
Treatments
Active_comparator: 10% Povidone-Iodine Arm
A single-use sealed packet of three 10% povidone-iodine swabs will be opened via standard sterile technique. Three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing an Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, an additional culture will be obtained with an Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with an Eswab just prior to wound closure.
Active_comparator: Saline Arm
Three sterile swabs will be provided for soaking in sterile saline. Three applications of sterile saline along the length of the subdermis, using each of the 3 swabs soaked in sterile saline. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing and Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, and additional culture will be obtained with and Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with and Eswab just prior to wound closure.
Related Therapeutic Areas
Sponsors
Leads: Akron Children's Hospital