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
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Condition or disease | Intervention/treatment |
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Cleft Palate | Device: Acellular Dermal Matrix |
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:
- Incidence of wound dehiscence
- Incidence of wound infection
- 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 |
Actual Primary Completion Date : | December 31, 2016 |
Actual Study Completion Date : | March 31, 2017 |
Group/Cohort | Intervention/treatment |
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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.
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Device: Acellular Dermal Matrix
Other Name: DermaMatrix
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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).
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- Fistula Formation [ Time Frame: Within 1 year of surgery ]Number of patients who developed post palatoplasty fistula
- Number of Participants With Wound Infection [ Time Frame: Within 1 year of surgery ]Number of Participants with Wound Infection post cleft palate repair

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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 |
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.

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 |
Principal Investigator: | Mirko , S Gilardino, MD | Montreal Children's Hospital of the MUHC |
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 |
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:
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 |