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Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial (NCT03028272)

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.
  • 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
      Ages eligible for Study
      3 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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
      A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.
      Status:
      enrolling by invitation
      Type:
      Interventional
      Phase:
      -
      Start:
      31 December, 2016
      Updated:
      18 January, 2017
      Participants:
      50
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