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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular Dermal Matrix | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fistula Formation | Number of patients who developed post palatoplasty fistula | Within 1 year of surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Mirko, S Gilardino, MD | Montreal Children's Hospital of the MUHC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Children's Hospital | Montreal | Quebec | H3H1P3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22743882 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Retrospective Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fistula Formation | Number of patients who developed post palatoplasty fistula | Posted | Number | participants | Within 1 year of surgery |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mirko Gilardino | MUHC | 514.934.1934 | Mirko.Gilardino@muhc.mcgill.ca |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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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). |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Wound Infection | Number of Participants with Wound Infection post cleft palate repair | Posted | Count of Participants | Participants | Within 1 year of surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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). | 0 | 0 | 0 | 0 | 0 | 0 |
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| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |