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

Lagos State Ministry of Education

Status: Completed

Conditions: Cleft Palate; Cleft Lip and Cleft Palate; Cleft Lip, Cleft Alveolus and Cleft Palate

Treatments: Procedure: Two-flap palatoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT05454670

ADM/DST/HREC/VOL.XVII/763

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 12 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Procedure: Two-flap palatoplasty

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Two-flap palatoplasty