Clinical trial NCT01867632: Acellular Dermal Matrix in Primary Palatoplasty
Official title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cleft Palate
Keywords: Palatoplasty
Acellular Dermal Matrix
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 131
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who present to the Montreal Children's Hospital with a cleft palate (Veau II-IV) that undergo surgical repair between the age of 3 months and 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 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.

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 cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.

Objectives of the study:

Primary objectives:

The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.

Secondary objectives:

1. Incidence of wound dehiscence
2. Incidence of wound infection
3. Hospital length of stay

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Fistula Formation
timeFrame: Within 1 year of surgery
Secondary outcomes:
measure: Number of Participants With Wound Infection
timeFrame: Within 1 year of surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Montreal Children's Hospital of the MUHC
name: Mirko, S Gilardino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012 Jul;130(1):177-182. doi: 10.1097/PRS.0b013e318254b2dc.