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

Not Applicable

Completed

• Conditions: Cleft Palate; Cleft Lip, Cleft Alveolus and Cleft Palate; Cleft Lip and Cleft Palate
• Interventions: Procedure: Two-flap palatoplasty

• Registration Number: NCT05454670
• Lead Sponsor: Lagos State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-08-10
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Two-flap palatoplasty	The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft
Test group	Two-flap palatoplasty	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative palatal fistula	One month 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 Outcome Measures

Name	Time	Method
Number of participants with wound dehiscence	One month 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	One month 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	One month 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).

Trial Locations

Locations (1)

Lagos University Teaching Hospital; 🇳🇬 Lagos, Nigeria