Acellular Dermal Matrix in Primary Furlow Palatoplasty
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2013 by McGill University Health Center
Sponsor:
Mirko S. Gilardino
Information provided by (Responsible Party):
Mirko S. Gilardino, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01867632
First received: May 25, 2013
Last updated: May 29, 2013
Last verified: May 2013
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Purpose
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 | Intervention |
|---|---|
|
Cleft Palate |
Device: Acellular Dermal Matrix |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Furlow Palatoplasty |
Resource links provided by NLM:
Further study details as provided by McGill University Health Center:
Primary Outcome Measures:
- Fistula formation [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Wound infection [ Time Frame: Within 1 year of surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Acellular Dermal Matrix
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
|
Detailed Description:
Observational study composed of a prospective cohort group receiving ADM compared to a retrospective historical cohort group without ADM.
Objectives of the study:
Primary objectives:
The primary objective of this study is to determine whether ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.
Secondary objectives:
- Incidence of wound dehiscence
- Incidence of wound infection
- Hospital length of stay
Eligibility| Ages Eligible for Study: | 3 Months to 3 Years |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867632
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867632
Contacts
| Contact: Mirko S Gilardino, MD | 514.934.1934 ext 23472 |
Locations
| Canada, Quebec | |
| Montreal Children's Hospital | Recruiting |
| Montreal, Quebec, Canada, H3H1P3 | |
| Principal Investigator: Mirko S. Gilardino, MD MSc FRCSC | |
Sponsors and Collaborators
Mirko S. Gilardino
Investigators
| Principal Investigator: | Mirko , S Gilardino, MD | Montreal Children's Hospital of the MUHC |
More Information
Publications:
| 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 |
| Study First Received: | May 25, 2013 |
| Last Updated: | May 29, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University Health Center:
|
Furlow Palatoplasty Acellular Dermal Matrix |
Additional relevant MeSH terms:
|
Jaw Diseases Cleft Palate Congenital Abnormalities Craniofacial Abnormalities Jaw Abnormalities Maxillofacial Abnormalities |
Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities |
ClinicalTrials.gov processed this record on February 25, 2015