WithdrawnNot Applicable

Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

Stopped: Lack of qualified participants

0Started 2017-01-01

Plain-language summary

The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Who can participate

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Presence of a tympanic membrane perforation
✓. Patient at PI's clinic

Exclusion criteria

✕. Presence of cholesteatoma
✕. Prior surgery on the same-sided TM or middle ear
✕. Ossicular chain abnormalities
✕. Congenital deformities involving the middle ear or eustachian tube
✕. Refusal to undergo surgery

What they're measuring

Comparable or improved performance of Skye ActiveBarrier

Timeframe: 12-18 months

Trial details

NCT IDNCT03028272

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Tympanic Membrane Perforation trials