Acellular Dermal Matrix in Primary Palatoplasty

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Cleft Palate	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 Design

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Study Type :	Observational
Actual Enrollment :	131 participants
Observational Model:	Cohort
Time Perspective:	Other
Official Title:	Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
Study Start Date :	September 2012
Actual Primary Completion Date :	December 31, 2016
Actual Study Completion Date :	March 31, 2017

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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).

Outcome Measures

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Primary Outcome Measures :

1. Fistula Formation [ Time Frame: Within 1 year of surgery ]
   Number of patients who developed post palatoplasty fistula

Secondary Outcome Measures :

1. Number of Participants With Wound Infection [ Time Frame: Within 1 year of surgery ]
   Number of Participants with Wound Infection post cleft palate repair

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	3 Months to 3 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Mirko S. Gilardino

Investigators

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

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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):177-82. doi: 10.1097/PRS.0b013e318254b2dc. Review.

Responsible Party:	Mirko S. Gilardino, Director, Plastic Surgery Residency Program, Assistant Professor of Surgery, McGill University Health Center
ClinicalTrials.gov Identifier:	NCT01867632 History of Changes
Other Study ID Numbers:	12-073-PED
First Posted:	June 4, 2013
Results First Posted:	June 16, 2017
Last Update Posted:	July 21, 2017
Last Verified:	June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Mirko S. Gilardino, McGill University Health Center:

Palatoplasty; Acellular Dermal Matrix

Additional relevant MeSH terms:

Cleft Palate; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities	Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities