Acellular Dermal Matrix in Primary Palatoplasty

Completed

• Conditions: Cleft Palate
• Interventions: Device: Acellular Dermal Matrix

• Registration Number: NCT01867632
• Lead Sponsor: Mirko S. Gilardino

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 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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-05-25
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-04
• Primary Completion: 2016-12-31
• Study Completion: 2017-03-31
• Results First Submitted: 2017-04-01
• Results First Submitted QC: 2017-04-01
• Status Verified: 2017-06
• Results First Posted: 2017-06-16
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective group	Acellular Dermal Matrix	Prospective cohort where all patients routinely received ADM during cleft palate surgery. 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.

Primary Outcome Measures

Name	Time	Method
Fistula Formation	Within 1 year of surgery	Number of patients who developed post palatoplasty fistula

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Wound Infection	Within 1 year of surgery	Number of Participants with Wound Infection post cleft palate repair

Trial Locations

Locations (1)

Montreal Children's Hospital; 🇨🇦 Montreal, Quebec, Canada