NCT01867632

Acellular Dermal Matrix in Primary Palatoplasty

Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Mirko S. Gilardino · Academic / Other
• Sex: All
• Age: 3 Months – 3 Years
• Healthy volunteers: Not accepted

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 description

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: Primary objectives: 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. Secondary objectives: 1. Incidence of wound dehiscence 2. Incidence of wound infection 3. Hospital length of stay

Conditions

• Cleft Palate

Interventions

Type	Name	Description
DEVICE	Acellular Dermal Matrix

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-12-31
• Completion: 2017-03-31
• First posted: 2013-06-04
• Last updated: 2017-07-21
• Results posted: 2017-06-16

Locations

1 site across 1 country: Canada