Clinical trial NCT05454670: Effect of Collagen Matrix Graft on Palatal Fistula Formation After Cleft Palate Repair
Official title: The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip and Cleft Palate
Cleft Lip, Cleft Alveolus and Cleft Palate
Cleft Palate
Keywords: cleft palate
palatal fistula
collagen graft
Lead sponsor: Lagos State University
Sponsor class: OTHER
Collaborators: name: University of Lagos, Nigeria
First posted: 2022-07-12
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of participants with postoperative palatal fistula
timeFrame: 24 hours post operatively
measure: Number of participants with postoperative palatal fistula
timeFrame: Seven days post operatively
measure: Number of participants with postoperative palatal fistula
timeFrame: Two weeks post operatively
measure: Number of participants with postoperative palatal fistula
timeFrame: One month post operatively
Secondary outcomes:
measure: Number of participants with wound dehiscence
timeFrame: 24 hours post operatively
measure: Number of participants with wound dehiscence
timeFrame: Seven days post operatively
measure: Number of participants with wound dehiscence
timeFrame: Two weeks post operatively
measure: Number of participants with wound dehiscence
timeFrame: One month post operatively
measure: Number of participants with surgical site inflammation
timeFrame: 24 hours post operatively
measure: Number of participants with surgical site inflammation
timeFrame: Seven days post operatively
measure: Number of participants with surgical site inflammation
timeFrame: Two weeks post operatively
measure: Number of participants with surgical site inflammation
timeFrame: One month post operatively
measure: Number of participants with surgical site infection
timeFrame: 24 hours post operatively
measure: Number of participants with surgical site infection
timeFrame: Seven days post operatively
measure: Number of participants with surgical site infection
timeFrame: Two weeks post operatively
measure: Number of participants with surgical site infection
timeFrame: One month post operatively
measure: Surgeon satisfaction
timeFrame: within the first 24 hours post operatively
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
References: