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Acellular Dermal Matrix in Primary Furlow Palatoplasty

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by McGill University Health Center
Information provided by (Responsible Party):
Mirko S. Gilardino, McGill University Health Center Identifier:
First received: May 25, 2013
Last updated: March 18, 2016
Last verified: March 2016
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.

Condition Intervention
Cleft Palate
Device: Acellular Dermal Matrix

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Fistula formation [ Time Frame: Within 1 year of surgery ]

Secondary Outcome Measures:
  • Wound infection [ Time Frame: Within 1 year of surgery ]

Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acellular Dermal Matrix
A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.
Device: Acellular Dermal Matrix
Other Name: DermaMatrix

Detailed Description:

Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group without ADM.

Objectives of the study:

Primary objectives:

The primary objective of this study is to determine whether 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

Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01867632

Contact: Mirko S Gilardino, MD 514.934.1934 ext 23472

Canada, Quebec
Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H3H1P3
Principal Investigator: Mirko S. Gilardino, MD MSc FRCSC         
Sponsors and Collaborators
Mirko S. Gilardino
Principal Investigator: Mirko , S Gilardino, MD Montreal Children's Hospital of the MUHC
  More Information

Responsible Party: Mirko S. Gilardino, Director, Plastic Surgery Residency Program, Assistant Professor of Surgery, McGill University Health Center Identifier: NCT01867632     History of Changes
Other Study ID Numbers: 12-073-PED
Study First Received: May 25, 2013
Last Updated: March 18, 2016

Keywords provided by McGill University Health Center:
Furlow Palatoplasty
Acellular Dermal Matrix

Additional relevant MeSH terms:
Jaw Diseases
Cleft Palate
Jaw Abnormalities
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities processed this record on April 27, 2017