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

Cleft Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454670
• Other study ID #: ADM/DST/HREC/VOL.XVII/763
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: Lagos State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate
• Fistula

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Nigeria	Lagos University Teaching Hospital	Lagos

Sponsors (2)

Lead Sponsor	Collaborator
Lagos State University	University of Lagos, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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