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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
48
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
Lagos University Teaching Hospital
Lagos, Nigeria
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One month 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: within the first 24 hours post operatively
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