Acellular Dermal Matrix in Primary Palatoplasty
|Study Design:||Observational Model: Cohort
Time Perspective: Other
|Official Title:||Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty|
- 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
|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)|
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).
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867632
|Montreal Children's Hospital|
|Montreal, Quebec, Canada, H3H1P3|
|Principal Investigator:||Mirko , S Gilardino, MD||Montreal Children's Hospital of the MUHC|