Cleft Lip and Cleft Palate, Cleft Lip, Cleft Alveolus and Cleft Palate, Cleft Palate
Conditions
Keywords
cleft palate, palatal fistula, collagen graft
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.
Interventions
PROCEDURETwo-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
Sponsors
University of Lagos, Nigeria
Lagos State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
This study will be a double-blind randomized controlled study. After random allocation, the participants (parents/ patients) will be unaware of the study group they belong to. Also, the surgeon assessing postoperative outcomes will not perform the surgery and will be unaware of the study group of the participant being examined. Since the collagen graft will be placed between the nasal/ muscular layers and the oral layer, it is expected that after apposition of the oral layer, no collagen matrix will be visible intraorally to reveal the study group of participants.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
12 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative palatal fistula | 24 hours post operatively | Palatal fistula will be defined as a patency between the oral and nasal cavities developing postoperatively anywhere along the primary or secondary palate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with wound dehiscence | 24 hours post operatively | Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation. |
| Number of participants with surgical site inflammation | 24 hours post operatively | Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site. |
| Number of participants with surgical site infection | 24 hours post operatively | Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site |
| Surgeon satisfaction | within the first 24 hours post operatively | 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). |
Countries
Nigeria
Outcome results
None listed