Acellular Dermal Matrix in Primary Furlow Palatoplasty
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.
|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|