Acellular Dermal Matrix in Primary Palatoplasty

Mirko S. Gilardino131 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

131

Conditions

Cleft Palate

Interventions

Acellular Dermal MatrixDEVICE

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 3 Years

Medical Language ↔ Plain English

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.

Locations (1)

Montreal Children's Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Fistula Formation

Number of patients who developed post palatoplasty fistula

Time frame: Within 1 year of surgery

Secondary Outcomes

Number of Participants With Wound Infection

Number of Participants with Wound Infection post cleft palate repair

Time frame: Within 1 year of surgery

Data from ClinicalTrials.gov

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