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Effect of Chitodex Gel in Tympanoplasty Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 13, 2024 (before its estimated May 13, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: May 13, 2024 to May 13, 2025v3 Show 4 more changesShow less
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 5 to 6
    • Study description expanded, about 23 words
    • Site contacts updated at 1 of 2 sites
  2. Secondary endpoints: details revised at 1 of 5 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.
Trial Details
NCT Number NCT06260618
Lead Sponsor Central Adelaide Local Health Network Incorporated
Collaborators: University of Adelaide
Conditions
(from sponsor)		 Tympanic Membrane Perforation, Tympanic Membrane Inflammation, Surgery, Otitis Media
Related terms Otitis Media, Tympanic Membrane Perforation
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov