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
|Condition or disease||Intervention/treatment|
|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:
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.
- Incidence of wound dehiscence
- Incidence of wound infection
- Hospital length of stay
|Study Type :||Observational|
|Actual Enrollment :||131 participants|
|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|
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 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).
- 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
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
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H1P3|
|Principal Investigator:||Mirko , S Gilardino, MD||Montreal Children's Hospital of the MUHC|