Acellular Dermal Matrix in Primary Furlow Palatoplasty

Cleft Palate Clinical Trial

Official title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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:

1. Incidence of wound dehiscence

2. Incidence of wound infection

3. Hospital length of stay ;

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Cleft Palate

• NCT number: NCT01867632
• Study type: Observational
• Source: McGill University Health Center
• Contact: Mirko S Gilardino, MD
• Phone: 514.934.1934
• Status: Recruiting
• Phase: N/A
• Start date: September 2012
• Completion date: September 2016