Effect of Collagen Matrix Graft on Palatal Fistula Formation After Cleft Palate Repair
NCT ID: NCT05454670
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2022-08-10
2024-06-30
Brief Summary
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Closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. However, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. Till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. And although the use of pre-surgical appliances such as Latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair.
Collagen grafts have the added advantage of being more patient friendly compared to the Latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. They are also less technique sensitive compared to the use of local and distant tissues.
The investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Test group
The intervention will be primary cleft palate repair using resorbable collagen matrix graft as superpositional graft during approximation of the nasal mucosa and muscular layer in cleft palate repair. The collagen graft with be inserted between the nasal mucosa/ muscular layer and the oral mucosa layer during two-flap palatoplasty.
Two-flap palatoplasty
Two-flap palatoplasty used to correct cleft palate defect. The cleft palate is closed by separation of the nasal and the oral mucosa layers. Then approximation of the nasal mucosa layer, muscle layer is secured in the posterior palate and then the oral mucosa layer is secured
Control group
The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft
Two-flap palatoplasty
Two-flap palatoplasty used to correct cleft palate defect. The cleft palate is closed by separation of the nasal and the oral mucosa layers. Then approximation of the nasal mucosa layer, muscle layer is secured in the posterior palate and then the oral mucosa layer is secured
Interventions
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Two-flap palatoplasty
Two-flap palatoplasty used to correct cleft palate defect. The cleft palate is closed by separation of the nasal and the oral mucosa layers. Then approximation of the nasal mucosa layer, muscle layer is secured in the posterior palate and then the oral mucosa layer is secured
Eligibility Criteria
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Inclusion Criteria
* Must be between nine months to two years
* Must have not previously had cleft palate surgery
* Must consent to participate in the study
Exclusion Criteria
* All connective tissue dysfunctions
12 Months
6 Years
ALL
No
Sponsors
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University of Lagos, Nigeria
OTHER
Lagos State University
OTHER
Responsible Party
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Egbunah Uchenna Patrick
Senior Registrar
Locations
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Lagos University Teaching Hospital
Lagos, , Nigeria
Countries
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Other Identifiers
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ADM/DST/HREC/VOL.XVII/763
Identifier Type: -
Identifier Source: org_study_id
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