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

NCT05454670 | Completed

• 1 other identifier: ADM/DST/HREC/VOL.XVII/763
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Cleft Palate; Cleft Lip, Cleft Alveolus and Cleft Palate; Cleft Palate

Keywords

cleft palate; palatal fistula; collagen graft

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• Number of participants with wound dehiscence

  24 hours post operatively

• Number of participants with wound dehiscence

  Seven days post operatively

• Number of participants with wound dehiscence

  Two weeks post operatively

• Number of participants with wound dehiscence

  One month post operatively

• Number of participants with surgical site inflammation

  24 hours post operatively

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft

Procedure: Two-flap palatoplasty

Interventions

Two-flap palatoplasty PROCEDURE

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

Control group; Test group

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• All blood dyscrasias
• All connective tissue dysfunctions

Sponsors & Collaborators

• Lagos State University: lead
• University of Lagos, Nigeria: collaborator

Study Sites (1)

Lagos University Teaching Hospital

Lagos, 12003, Nigeria

Location

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Model Details: 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

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 12, 2022
• Study Start: August 10, 2022
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

NG (1)