A Prospective Study Investigating Fistula Rate Following Primary Palatoplasty Using Acellular Dermal Matrix.

ABSTRACT:

Background

Acellular dermal matrix (ADM) has been described as an adjunct in primary cleft palate repair to reduce the fistula rate in several retrospective studies (level III or lower); however, current data are insufficient to definitively conclude its efficacy for this purpose. The goal of the present study was to provide prospective, higher level of evidence data investigating the effect of ADM on fistula rate following primary palatoplasty.

Methods

A prospective clinical trial was conducted in which ADM was used uniformly in all primary cleft palate repairs that met inclusion criteria. For comparison, a matched control group was identified (retrospectively) from the same center/surgeon's database. Primary outcome was the rate of palatal fistula formation. Secondary outc

SUBMITTER: Gilardino MS 

PROVIDER: S-EPMC6157948 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature