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Acellular Dermal Matrix in Primary Palatoplasty

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ClinicalTrials.gov Identifier: NCT01867632
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : June 16, 2017
Last Update Posted : July 21, 2017
Information provided by (Responsible Party):
Mirko S. Gilardino, McGill University Health Center

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.

Condition or disease Intervention/treatment
Cleft Palate Device: Acellular Dermal Matrix

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

Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
Study Start Date : September 2012
Primary Completion Date : December 31, 2016
Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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).

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867632

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

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
First Posted: June 4, 2013    Key Record Dates
Results First Posted: June 16, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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