Cleft Lip and Cleft PalateNCT05454670
Effect of Collagen Matrix Graft on Palatal Fistula Formation After Cleft Palate Repair
A study testing Two-flap palatoplasty in people with Cleft Lip and Cleft Palate and Cleft Lip, Cleft Alveolus and Cleft Palate, run by Lagos State University at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Cleft Lip and Cleft Palate, Cleft Lip, Cleft Alveolus and Cleft Palate, Cleft Palate
- What is being tested?
- Two-flap palatoplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNigeria
- Study dates
- 10 Aug 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- All blood dyscrasias
- All connective tissue dysfunctions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair: A Randomized Controlled Study
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.
Read more
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.
- Being tested
- Two-flap palatoplasty
- Keywords
- cleft palate, palatal fistula, collagen graft
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-flap palatoplastyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Two-flap palatoplasty |
| Control group | Active comparator | The intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft Receives: Procedure: Two-flap palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: One month post operatively
Secondary outcomes (13)
Number of participants with wound dehiscence
Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation.
Measured: 24 hours post operatively
Number of participants with wound dehiscence
Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation.
Measured: Seven days post operatively
Number of participants with wound dehiscence
Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation.
Measured: Two weeks post operatively
Number of participants with wound dehiscence
Wound dehiscence will be defined as partial or total separation of previously approximated and sutured surgical wound edges with or without palatal fistula formation.
Measured: One month post operatively
Number of participants with surgical site inflammation
Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.
Measured: 24 hours post operatively
Number of participants with surgical site inflammation
Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.
Measured: Seven days post operatively
Number of participants with surgical site inflammation
Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.
Measured: Two weeks post operatively
Number of participants with surgical site inflammation
Surgical site inflammation will be defined as tenderness, redness, swelling and/or differential warmth from surgical site.
Measured: One month post operatively
Number of participants with surgical site infection
Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site
Measured: 24 hours post operatively
Number of participants with surgical site infection
Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site
Measured: Seven days post operatively
Number of participants with surgical site infection
Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site
Measured: Two weeks post operatively
Number of participants with surgical site infection
Surgical site infection will be defined as tenderness and purulent discharge and/or foul smelling odor from surgical site
Measured: One month post operatively
Surgeon satisfaction
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).
Measured: within the first 24 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start10 Aug 2022
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lagos, Nigeria
- Responsible party
- Principal investigator, Egbunah Uchenna Patrick, University of Lagos, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454670
- Sponsor's protocol ID
- ADM/DST/HREC/VOL.XVII/763
- Status last verified
- Oct 2024
- First submitted
- 2 Jul 2022
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Collagen Matrix Graft on Postoperative Palatal Fistula Formation After Cleft Palate Repair: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05454670
- Acronym / sponsor ID
- ADM/DST/HREC/VOL.XVII/763
- Keywords
- cleft palate, palatal fistula, collagen graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Collaborators
- University of Lagos, Nigeria
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Two-flap palatoplastyThe 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. |
| Control group | Active comparator | Procedure: Two-flap palatoplastyThe intervention will be primary cleft palate repair using two-flap palatoplasty technique without collagen graft |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- All blood dyscrasias
- All connective tissue dysfunctions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-flap palatoplastyTwo-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 | Procedure or surgery | Control group, Test group |
Primary outcome
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
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
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
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
13 secondary outcomes
Number of participants with wound dehiscence
Time frame: 24 hours post operatively
Number of participants with wound dehiscence
Time frame: Seven days post operatively
Number of participants with wound dehiscence
Time frame: Two weeks post operatively
Number of participants with wound dehiscence
Time frame: One month post operatively
Number of participants with surgical site inflammation
Time frame: 24 hours post operatively
Number of participants with surgical site inflammation
Time frame: Seven days post operatively
Number of participants with surgical site inflammation
Time frame: Two weeks post operatively
Number of participants with surgical site inflammation
Time frame: One month post operatively
Number of participants with surgical site infection
Time frame: 24 hours post operatively
Number of participants with surgical site infection
Time frame: Seven days post operatively
Number of participants with surgical site infection
Time frame: Two weeks post operatively
Number of participants with surgical site infection
Time frame: One month post operatively
Surgeon satisfaction
Time frame: within the first 24 hours post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-flap palatoplasty in people with Cleft Lip and Cleft Palate and Cleft Lip, Cleft Alveolus and Cleft Palate, run by Lagos State University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative palatal fistula (time frame: 24 hours post operatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.