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Completed

NCT Number: NCT05454670

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

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.

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Key information

Conditions

Cleft Lip and Cleft Palate Cleft Lip Cleft Lip, Cleft Alveolus and Cleft Palate Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

12 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lagos University Teaching Hospital

Lagos, 12003, Nigeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of participants with postoperative palatal fistula

    Time frame: 24 hours 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

  2. Number of participants with postoperative palatal fistula

    Time frame: Seven days 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

  3. Number of participants with postoperative palatal fistula

    Time frame: Two weeks 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

  4. Number of participants with postoperative palatal fistula

    Time frame: 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 outcomes

  1. Number of participants with wound dehiscence

    Time frame: 24 hours 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.

  2. Number of participants with wound dehiscence

    Time frame: Seven days 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.

  3. Number of participants with wound dehiscence

    Time frame: Two weeks 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.

  4. Number of participants with wound dehiscence

    Time frame: 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.

  5. Number of participants with surgical site inflammation

    Time frame: 24 hours post operatively

    Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.

  6. Number of participants with surgical site inflammation

    Time frame: Seven days post operatively

    Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.

  7. Number of participants with surgical site inflammation

    Time frame: Two weeks post operatively

    Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.

  8. Number of participants with surgical site inflammation

    Time frame: One month post operatively

    Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.

  9. Number of participants with surgical site infection

    Time frame: 24 hours post operatively

    Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site

  10. Number of participants with surgical site infection

    Time frame: Seven days post operatively

    Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site

  11. Number of participants with surgical site infection

    Time frame: Two weeks post operatively

    Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site

  12. Number of participants with surgical site infection

    Time frame: One month post operatively

    Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site

  13. Surgeon satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Lagos State University

Other

Collaborators

  • University of Lagos, Nigeria

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2022
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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