Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

Part of paid clinical trials in Akron, Ohio.

Sponsor
Akron Children's Hospital
Study ID
NCT06744907
Phase
PHASE4
Status
Recruiting
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Conditions

  • Spinal Fusion

Eligibility Criteria

Sex
ALL
Age
N/A - 26 Years
Healthy Volunteers
Not accepted

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.
  • Saline Arm — PROCEDURE
    An application of saline in the subdermal layer after making an incision.

Study Details

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.

Key Dates

Start date
Jan 3, 2025
Status verified
Jan 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Akron Children's HospitalAkronOhio44308
Alexandria Rundell, BS
[email protected]
330-543-3193
Lorena Floccari, MD
[email protected]
330-543-3193
Lorena Floccari, MD (PRINCIPAL_INVESTIGATOR)
Todd Ritzman, MD (SUB_INVESTIGATOR)
Richard Steiner, PhD (SUB_INVESTIGATOR)
Alexandria Rundell, BS (SUB_INVESTIGATOR)
Xiaotian Zheng, PhD (SUB_INVESTIGATOR)

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By research site
Akron Children's Hospital· Akron, OH

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