Recruiting

Povidone-Iodine

Sponsor:

Akron Children's Hospital

Code:

NCT06744907

Conditions

Spinal Fusion

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

Interventions

10% Povidone-Iodine Arm

Saline Arm

Study Details

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

Study ID

NCT06744907

Start date

Jan 3, 2025

Status verified date

Jan, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 26

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

10% Povidone-Iodine Arm

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

Saline Arm

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

Primary outcome measure

  • 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). [ Time Frame: From enrollment to one year post operative. ]

Central Contacts and Locations

Central contacts

Alexandria Rundell, BS

330-543-3193arundell@akronchildrens.org

Lorena Floccari, MD

330-543-3193lfloccari@akronchildrens.org

Locations

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Alexandria Rundell, BS

330-543-3193arundell@akronchildrens.org

Lorena Floccari, MD

330-543-3193lfloccari@akronchildrens.org

Principal Investigator:

Lorena Floccari, MD

More Information

Sponsor

Akron Children's Hospital

Last update posted

Jan 13, 2025

Last verified

Jan, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akron Children's Hospital on 2025-01-13.