Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

NCT06744907 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-114
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Fusion

Keywords

Spinal Fusion; Lumbar Spine; Thoracic Spine; Subdermal Betadine; Microbacterial bioburden

Outcome Measures

Primary Outcomes (1)

• 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).

  1. The skin, along the length of the planned incision 2. The subdermis before application of povidone-iodine versus control with saline 3. The subdermis after application of povidone-iodine versus control with saline) 4. The deep surgical wound after exposure 5. The deep surgical wound after all corrective maneuvers are complete, before closure

  From enrollment to one year post operative.

Secondary Outcomes (1)

• To report the incidence of treatment-related and other adverse events, including allergic.

  From enrollment to one year post operative.

Other Outcomes (1)

• 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.

  From enrollment to one year post operative.

Study Arms (2)

10% Povidone-Iodine Arm

ACTIVE COMPARATOR

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

Saline Arm

ACTIVE COMPARATOR

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

Interventions

10% Povidone-Iodine Arm BIOLOGICAL

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

10% Povidone-Iodine Arm

Saline Arm PROCEDURE

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

Saline Arm

Eligibility Criteria

• Age: Up to 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Central Study Contacts

Alexandria Rundell, BS

CONTACT

330-543-3193; arundell@akronchildrens.org

Lorena Floccari, MD

CONTACT

330-543-3193; lfloccari@akronchildrens.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Director Spine Center of Excellence, Director Spine Research

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 20, 2024
• Study Start: January 3, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)