Acellular Dermal Matrix in Primary Furlow Palatoplasty
|Study Design:||Observational Model: Cohort|
|Official Title:||Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty|
- Fistula formation [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]
- Wound infection [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Acellular Dermal Matrix
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
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group without ADM.
Objectives of the study:
The primary objective of this study is to determine whether 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
|Contact: Mirko S Gilardino, MD||514.934.1934 ext 23472|
|Montreal Children's Hospital||Recruiting|
|Montreal, Quebec, Canada, H3H1P3|
|Principal Investigator: Mirko S. Gilardino, MD MSc FRCSC|
|Principal Investigator:||Mirko , S Gilardino, MD||Montreal Children's Hospital of the MUHC|