Acellular Dermal Matrix in Primary Furlow Palatoplasty

Cleft Palate Clinical Trial

Official title:

Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01867632
• Other study ID #: 12-073-PED
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2013
• Last updated: April 6, 2015
• Start date: September 2012
• Est. completion date: September 2016

Study information

• Verified date: April 2015
• Source: McGill University Health Center
• Contact: Mirko S Gilardino, MD
• Phone: 514.934.1934
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 3 Years

Eligibility

Inclusion Criteria:

• Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.

Exclusion Criteria:

• Selection will be based on the parent's willingness to allow their child to participate in the study.

• Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.

• Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.

• Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Device:
• Acellular Dermal Matrix

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Mirko S. Gilardino

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012 Jul;130(1):177-82. doi: 10.1097/PRS.0b013e318254b2dc. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula formation		Within 1 year of surgery	No
Secondary	Wound infection		Within 1 year of surgery	No