At a glance
ClinicalIndex Comparison RecordN/ACompleted· 131 enrolled
Drug / intervention
Acellular Dermal Matrixdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
In Brief
An observational study evaluating Acellular Dermal Matrix for Cleft Palate. Completed, enrolled 131 participants across 1 site.
Detailed Summary
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCleft Palate
CountriesCanada
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2012
First PostedJun 2013
Primary CompletionDec 2016
Study CompletionMar 2017
TodayJul 2026
First PostedJun 4, 2013
Enrollment StartSep 1, 2012
Primary CompletionDec 31, 2016
Study CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.1 years ago
Interventions
Acellular Dermal Matrixdevice