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

Last updated: October 7, 2024
Sponsor: Lagos State University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Two-flap palatoplasty

Clinical Study ID

NCT05454670
ADM/DST/HREC/VOL.XVII/763
  • Ages 12-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • All blood dyscrasias

  • All connective tissue dysfunctions

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: Two-flap palatoplasty
Phase:
Study Start date:
August 10, 2022
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • Lagos University Teaching Hospital

    Lagos, 12003
    Nigeria

    Site Not Available

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