Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

Subdermal Betadine to Reduce Microbacterial Bioburden During Posterior Spinal Fusion

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Fusion
• Intervention / Treatment: Biological: 10% Povidone-Iodine Arm; Procedure: Saline Arm

Detailed 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 observed.

Once identified, the surgeon and coordinators will discuss risks, benefits, advantages, and disadvantages of this study to eligible patients. If the family wishes to enroll, the patient's family and patient will be consented. And automatically randomized to either povidone-iodine vs control group (predetermined according to the statistician). All patients will follow the standardized spine pathway including standard antibiotics and skin preparation with isopropyl alcohol followed by ChloraPrepTM and sterile draping. Five bacterial cultures will be obtained throughout the spinal fusion similarly for all patients by rubbing along the entirety of the posterior spinal incision. The first two cultures will be taken before the placement of an antimicrobial adhesive drape and after the initial incision in the subdermal layer. The surgeon will be notified which group the patients are in. Patients who were randomized to the povidone-iodine group will then have 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. Patients who were randomized to the control group will then have three applications of sterile saline along the length of the subdermis, using each of the 3 swab sticks soaked in sterile saline. Following the 10% povidone-iodine or saline application, the solution will be allowed to dry at least three minutes and a third culture will be obtained. Surgical exposure will proceed in all patients, and an additional culture will be obtained along the length of the deep wound after exposure, and a final culture along the length of the deep wound just prior to wound closure. The swabs will be cultured, and the final results will be reported however, the surgeons delivering patient care will be blinded to the results to mitigate competing interests. Routine postoperative care will follow standard of care no matter the culture results. A data safety monitor will assure no correlation between culture results and infection rate.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexandria Rundell, BS; Phone Number: 330-543-3193; Email: arundell@akronchildrens.org
• Study Contact Backup: Name: Lorena Floccari, MD; Phone Number: 330-543-3193; Email: lfloccari@akronchildrens.org

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Recruiting
      • Akron Children's Hospital
      • Contact: Alexandria Rundell, BS; Phone Number: 330-543-3193; Email: arundell@akronchildrens.org
      • Contact: Lorena Floccari, MD; Phone Number: 330-543-3193; Email: lfloccari@akronchildrens.org
      • Principal Investigator: Lorena Floccari, MD
      • Sub-Investigator: Todd Ritzman, MD
      • Sub-Investigator: Richard Steiner, PhD
      • Sub-Investigator: Alexandria Rundell, BS
      • Sub-Investigator: Xiaotian Zheng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: 10% Povidone-Iodine Arm; A second application of surgical antisepsis with a topical povidone-iodine in the subdermal layer after making an incision.
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.	Procedure: Saline Arm; An application of saline in the subdermal layer after making an incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the incidence of bacterial growth in five layers of the surgical wound between the treatment group (10% povidone-iodine) and the control group (saline).	The skin, along the length of the planned incision; The subdermis before application of povidone-iodine versus control with saline; The subdermis after application of povidone-iodine versus control with saline); The deep surgical wound after exposure; The deep surgical wound after all corrective maneuvers are complete, before closure	From enrollment to one year post operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To report the incidence of treatment-related and other adverse events, including allergic.	Secondary outcomes will be complications, including allergic reactions, contact dermatitis, surgical site infection and wound complications.	From enrollment to one year post operative.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To perform statistical correlations among locations/conditions and between treatment groups will be conducted in a generalized linear mixed model (GLMM) framework with a binomial distribution and a logit link function.	Age; Gender; Comorbidities; Body mass index (BMI); Operative time; Blood loss; Fusion levels; Scoliosis etiology; Curve type; Curve magnitude (Cobb angle); Use of prophylactic antibiotics; Hospital length of stay; Complications, including readmissions and reoperations.	From enrollment to one year post operative.

Collaborators and Investigators

• Sponsor: Akron Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Lumbar Spine; Spinal Fusion; Thoracic Spine; Subdermal Betadine; Microbacterial bioburden
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Povidone; Povidone-Iodine
• Other Study ID Numbers: 2024-114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No