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

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

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 Overview

• Status: Recruiting
• Conditions: Cleft Palate; Cleft Lip and Cleft Palate; Cleft Lip, Cleft Alveolus and Cleft Palate
• Intervention / Treatment: Procedure: Two-flap palatoplasty

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Lagos, Nigeria, 12003
    • Recruiting
    • Lagos University Teaching Hospital
    • Contact: Wasiu L Adeyemo, PhD; Phone Number: 234 8023115885; Email: lanreadeyemo@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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; 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
Active Comparator: Control group; The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft	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

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

Collaborators and Investigators

• Sponsor: Lagos State University
• Collaborators: University of Lagos, Nigeria

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cleft palate; palatal fistula; collagen graft
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Fistula; Cleft Palate; Cleft Lip
• Other Study ID Numbers: ADM/DST/HREC/VOL.XVII/763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No