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Acellular Dermal Matrix in Primary Palatoplasty

NCT01867632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 131

Last updated 2017-07-21

Study results available
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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.

Conditions

  • Cleft Palate

Interventions

DEVICE

Acellular Dermal Matrix

Sponsors & Collaborators

  • Mirko S. Gilardino

    lead OTHER

Principal Investigators

  • Mirko, S Gilardino, MD · Montreal Children's Hospital of the MUHC

Eligibility

Min Age
3 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • Canada

Study Locations

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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 NCT01867632 on ClinicalTrials.gov