Acellular Dermal Matrix in Primary Palatoplasty

NCT01867632 | Completed Results

• 1 other identifier: 12-073-PED
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Palate

Keywords

Palatoplasty; Acellular Dermal Matrix

Outcome Measures

Primary Outcomes (1)

• Fistula Formation

  Number of patients who developed post palatoplasty fistula

  Within 1 year of surgery

Secondary Outcomes (1)

• Number of Participants With Wound Infection

  Within 1 year of surgery

Study Arms (2)

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

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).

Interventions

Acellular Dermal Matrix DEVICE

Also known as: DermaMatrix

Prospective group

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirko S. Gilardino: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3H1P3, Canada

Location

Related 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):177-182. doi: 10.1097/PRS.0b013e318254b2dc.

  PMID: 22743882 BACKGROUND

MeSH Terms

Conditions

Cleft Palate

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Mirko Gilardino
• Organization: MUHC

Mirko.Gilardino@muhc.mcgill.ca

514.934.1934

Study Officials

• Mirko, S Gilardino, MD

  Montreal Children's Hospital of the MUHC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Plastic Surgery Residency Program, Assistant Professor of Surgery

Study Record Dates

• First Submitted: May 25, 2013
• First Posted: June 4, 2013
• Study Start: September 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: March 31, 2017
• Last Updated: July 21, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)