Status:
COMPLETED
Acellular Dermal Matrix in Primary Palatoplasty
Lead Sponsor:
Mirko S. Gilardino
Conditions:
Cleft Palate
Eligibility:
All Genders
3-3 years
Brief 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 individua...
Detailed Description
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all ...
Eligibility Criteria
Inclusion
- Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
Exclusion
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
- Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
- Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT01867632
Start Date
September 1 2012
End Date
March 31 2017
Last Update
July 21 2017
Active Locations (1)
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1
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H1P3