Clinical Trial: Acellular Dermal Matrix in Primary Furlow Palatoplasty
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty
Brief Summary: 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.
Detailed Summary:
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group without ADM.
Objectives of the study:
Primary objectives:
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.
Secondary objectives:
- Incidence of wound dehiscence
- Incidence of wound infection
- Hospital length of stay
Sponsor: Mirko S. Gilardino
Current Primary Outcome: Fistula formation [ Time Frame: Within 1 year of surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Wound infection [ Time Frame: Within 1 year of surgery ]
Original Secondary Outcome: Same as current
Information By: McGill University Health Center
Dates:
Date Received: May 25, 2013
Date Started: September 2012
Date Completion: September 2016
Last Updated: March 18, 2016
Last Verified: March 2016
