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Acellular Dermal Matrix in Primary Palatoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mirko S. Gilardino, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01867632
First received: May 25, 2013
Last updated: June 21, 2017
Last verified: June 2017
  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
Time Perspective: Other
Official Title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty

Resource links provided by NLM:


Further study details as provided by Mirko S. Gilardino, McGill University Health Center:

Primary Outcome Measures:
  • Fistula Formation [ Time Frame: Within 1 year of surgery ]
    Number of patients who developed post palatoplasty fistula


Secondary Outcome Measures:
  • Number of Participants With Wound Infection [ Time Frame: Within 1 year of surgery ]
    Number of Participants with Wound Infection post cleft palate repair


Enrollment: 131
Study Start Date: September 2012
Study Completion Date: March 31, 2017
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prospective group
Prospective cohort where all patients routinely received ADM during cleft palate surgery. 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
Retrospective group
Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).

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

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.
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
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 ClinicalTrials.gov identifier: NCT01867632

Locations
Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H1P3
Sponsors and Collaborators
Mirko S. Gilardino
Investigators
Principal Investigator: Mirko , S Gilardino, MD Montreal Children's Hospital of the MUHC
  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
Results First Received: April 1, 2017
Last Updated: June 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mirko S. Gilardino, McGill University Health Center:
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 August 17, 2017