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Short-term Application of Lactoferrin Ventilation Tubes
Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Summary
This study aims to evaluate the feasibility and preliminary biocompatibility of a novel lactoferrin-based ventilation tube and its manufacturing process for use in implantable medical materials. Patients with otitis media with effusion who are scheduled to undergo tympanostomy tube placement will be enrolled. Before insertion of the standard ventilation tube, the novel lactoferrin-based tube will be temporarily placed at the tympanic membrane incision site. Its handling characteristics and preliminary material properties will be assessed, including successful placement, mechanical strength, and structural integrity during manipulation. Local reactions of the tympanic membrane and surrounding tissues following brief contact will also be observed. The findings will provide preliminary evidence to support further material optimization and subsequent studies. This study is not intended to evaluate the long-term clinical efficacy or safety of the tube as an indwelling tympanostomy device.
Official title: Safety and Feasibility Evaluation of Lactoferrin Ventilation Tubes in the Short-term Application for Otitis Media With Effusion
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10-25
Completion Date
2027-01-31
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Ventilation tube insertion
A novel lactoferrin-based ventilation tube will be temporarily placed at the tympanic membrane incision site for approximately 10 minutes before routine tympanostomy tube insertion. Placement feasibility, material integrity, handling characteristics, and local tissue responses will be assessed.