Acellular Dermal Matrix in Primary Furlow Palatoplasty

This study is currently recruiting participants.
Verified May 2013 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Mirko S. Gilardino, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01867632
First received: May 25, 2013
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wound infection [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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
  Eligibility

Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867632

Contacts
Contact: Mirko S Gilardino, MD 514.934.1934 ext 23472

Locations
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
Investigators
Principal Investigator: Mirko , S Gilardino, MD Montreal Children's Hospital
  More Information

Publications:
Responsible Party: Mirko S. Gilardino, Director, Plastic Surgery Residency Program, Assistant Professor of Surgery, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01867632     History of Changes
Other Study ID Numbers: 12-073-PED
Study First Received: May 25, 2013
Last Updated: May 29, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 15, 2014