The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair

Study Overview
=================
Brief Summary
-----------------
Palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. Their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. Prevention of postoperative palatal fistula is therefore of paramount importance. 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.

Official Title
-----------------
The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair: A Randomized Controlled Study

Conditions
-----------------
Cleft Lip and Cleft Palate, Cleft Lip, Cleft Alveolus and Cleft Palate, Cleft Palate

Intervention / Treatment
-----------------
* Procedure: Two-flap palatoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-syndromic cleft palate 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 blood dyscrasias All connective tissue dysfunctions

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a parallel randomized controlled study involving two groups of participants. The test group will include participants with who will undergo cleft palate repair with collagen graft used as superpositional graft between the nasal mucosa/muscle layer and the oral mucosa layer when two-flap palatoplasty is performed while the control group will include participants who undergo two-flap palatoplasty without the use of collagen graft
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>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. | Procedure: Two-flap palatoplasty<br>* 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<br>|
| Active Comparator: Control group<br>The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft | Procedure: Two-flap palatoplasty<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative palatal fistula | Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate | 24 hours post operatively | 
| Number of participants with postoperative palatal fistula | Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate | Seven days post operatively | 
| Number of participants with postoperative palatal fistula | Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate | Two weeks post operatively | 
| Number of participants with postoperative palatal fistula | Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate | One month post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with wound dehiscence | Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation. | 24 hours post operatively | 
| Number of participants with wound dehiscence | Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation. | Seven days post operatively | 
| Number of participants with wound dehiscence | Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation. | Two weeks post operatively | 
| Number of participants with wound dehiscence | Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation. | One month post operatively | 
| Number of participants with surgical site inflammation | Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site. | 24 hours post operatively | 
| Number of participants with surgical site inflammation | Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site. | Seven days post operatively | 
| Number of participants with surgical site inflammation | Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site. | Two weeks post operatively | 
| Number of participants with surgical site inflammation | Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site. | One month post operatively | 
| Number of participants with surgical site infection | Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site | 24 hours post operatively | 
| Number of participants with surgical site infection | Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site | Seven days post operatively | 
| Number of participants with surgical site infection | Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site | Two weeks post operatively | 
| Number of participants with surgical site infection | Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site | One month post operatively | 
| Surgeon satisfaction | Surgeon satisfaction will assess surgeons' opinion on surgery time (normal/ extended), difficulty of procedure (not difficult/ increased difficulty) and inadvertent tearing of the nasal mucosa (absent/ present). | within the first 24 hours post operatively | 
| Psychology of parents towards surgical treatment | Psychology of parents towards surgical treatment will assess parents' psychology towards the aesthetic outcome of the cleft palate repair, its effect on their wards feeding and speech ability postoperatively | 24 hours post operatively | 
| Psychology of parents towards surgical treatment | Psychology of parents towards surgical treatment will assess parents' psychology towards the aesthetic outcome of the cleft palate repair, its effect on their wards feeding and speech ability postoperatively | Seven days post operatively | 
| Psychology of parents towards surgical treatment | Psychology of parents towards surgical treatment will assess parents' psychology towards the aesthetic outcome of the cleft palate repair, its effect on their wards feeding and speech ability postoperatively | Two weeks post operatively | 
| Psychology of parents towards surgical treatment | Psychology of parents towards surgical treatment will assess parents' psychology towards the aesthetic outcome of the cleft palate repair, its effect on their wards feeding and speech ability postoperatively | One month post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft palate, palatal fistula, collagen graft