Author(s)
Timothy Kearney, MS
Andrew E. Bluher, MD
Stephanie Moody-Antonio, MD
Affiliation(s)
Eastern Virginia Medical School; Children’s Hospital of the King’s Daughters
Abstract:
Background: Tympanic membrane perforations adversely affect patient quality of life, contributing to otorrhea, infections,
ear pain, water avoidance, and conductive hearing loss. The FDA recently approved the Biodesign® porcine small intestine
submucosal (SIS) graft, which offers the advantage of reduced operative time and site morbidity associated with autogenous
graft harvest.
Aims: (1) Compare outcomes between tympanoplasties that use autologous temporalis fascia versus those that use SIS
grafts. (2) Identify clinical factors that may predict surgical success or surgical failure, as defined by persistent perforation.
Study Design: Retrospective case control study
Setting: Tertiary pediatric hospital
Methods: Patients aged 2-16 years old who had a medial graft tympanoplasty performed by the senior author from 9/1/16
to 9/1/18 with either autogenous fascia or SIS xenograft were eligible for inclusion. Patients who had a concurrent
mastoidectomy or ossicular chain reconstruction were excluded. Patients who had a tympanoplasty using an SIS graft
were included as cases, while age-matched patients who had temporalis fascia graft tympanoplasties were included as
controls. Data regarding perforation size, grafting technique, graft location and mucosal descriptors were also obtained.
Results: Preliminary data shows a perforation healing rate of 72.7% in the Biodesign® group (N=11) and a perforation
healing rate of 84.2% in the control group (N=38). Data analysis which seeks to find any correlation between surgical
success and patient age, initial perforation size, or perforation location is currently in progress.
Conclusions: Further research is needed to confirm the efficacy of xenografts in a clinical setting.
Define Professional Practice Gap & Educational Need: There remains a need to critically evaluate xenografts for their
efficacy in tympanoplasty.
Learning Objective: Xenografts may have lower efficacy for medial graft tympanoplasty in a pediatric tertiary care setting.
Desired Result: Surgeons will continue to remain cognizant of potential for worsened tympanoplasty outcomes when using
xenografts in pediatric tertiary care settings, pending further data.
Level of Evidence - IV:
Indicate IRB or IACUC: IRB number: 19-05-XX-0144. Approved by Eastern Virginia Medical School Institutional
Review Board.