Acellular Dermal Matrix in Primary Palatoplasty

Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate
• Intervention / Treatment: Device: Acellular Dermal Matrix

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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3H1P3
      • Montreal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children who present to the Montreal Children's Hospital with a cleft palate (Veau II-IV) that undergo surgical repair between the age of 3 months and 3 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective group; 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.	Device: Acellular Dermal Matrix; Other Names: DermaMatrix
Retrospective group; Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula Formation	Number of patients who developed post palatoplasty fistula	Within 1 year of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Infection	Number of Participants with Wound Infection post cleft palate repair	Within 1 year of surgery

Collaborators and Investigators

• Sponsor: Mirko S. Gilardino
• Investigators: Principal Investigator: Mirko, S Gilardino, MD, Montreal Children's Hospital of the MUHC

Publications and helpful links

General Publications

• Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012 Jul;130(1):177-182. doi: 10.1097/PRS.0b013e318254b2dc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: May 25, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: June 21, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Acellular Dermal Matrix; Palatoplasty
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate
• Other Study ID Numbers: 12-073-PED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO