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Safety and Efficacy of Subdermal Betadine During Posterior Spinal Fusion

NCT06744907 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-13

No results posted yet for this study

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

Interventions

BIOLOGICAL

10% Povidone-Iodine Arm

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

PROCEDURE

Saline Arm

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

Sponsors & Collaborators

  • Akron Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Max Age
26 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2025-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744907 on ClinicalTrials.gov