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

NCT03028272 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-15

No results posted yet for this study

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.

Conditions

  • Tympanic Membrane Perforation

Interventions

OTHER

Skye Barrier

Substrate derived from amniotic tissue that is FDA-approved for human implantation

OTHER

Fascia

Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Arnaldo Rivera, M.D. · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

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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 NCT03028272 on ClinicalTrials.gov