Cleft PalateNCT01867632
Acellular Dermal Matrix in Primary Palatoplasty
An observational study of Cleft Palate, run by Mirko S. Gilardino at 1 site in Canada.
Trial summary
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Read more about this study
- Who is it for?
- Ages 3 months to 3 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Acellular Dermal Matrix
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 131 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to 31 Mar 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who present to the Montreal Children's Hospital with a cleft palate (Veau II-IV) that undergo surgical repair between the age of 3 months and 3 years.
Who may be able to join
- Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
Who cannot join
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
- Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
- Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
Read the detailed description
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.
Objectives of the study:
Primary objectives:
The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.
Secondary objectives:
- Incidence of wound dehiscence
- Incidence of wound infection
- Hospital length of stay
- Conditions
- Cleft Palate
- Being tested
- Acellular Dermal Matrix
- Keywords
- Palatoplasty, Acellular Dermal Matrix
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixDevice
Also called DermaMatrix
| Study group | Role | What they receive |
|---|---|---|
| Prospective group | Prospective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate. Receives: Device: Acellular Dermal Matrix | |
| Retrospective group | Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula Formation
Number of patients who developed post palatoplasty fistula
Measured: Within 1 year of surgery
Secondary outcomes (1)
Number of Participants With Wound Infection
Number of Participants with Wound Infection post cleft palate repair
Measured: Within 1 year of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startSep 2012
- Primary completion31 Dec 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirko S. Gilardino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mirko S. Gilardino, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Mirko, S Gilardino, MD, Principal investigator, Montreal Children's Hospital of the MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867632
- Sponsor's protocol ID
- 12-073-PED
- Status last verified
- Jun 2017
- First submitted
- 25 May 2013
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012 Jul;130(1):177-182. doi: 10.1097/PRS.0b013e318254b2dc.
PubMed 22743882
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acellular Dermal Matrix Reduce Fistula Rate in Primary Palatoplasty
- ClinicalTrials.gov ID
- NCT01867632
- Acronym / sponsor ID
- 12-073-PED
- Conditions
- Cleft Palate
- Keywords
- Palatoplasty, Acellular Dermal Matrix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Mirko S. GilardinoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.
Detailed description
There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.
Objectives of the study:
Primary objectives:
The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.
Secondary objectives:
- Incidence of wound dehiscence
- Incidence of wound infection
- Hospital length of stay
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group | – | Device: Acellular Dermal MatrixProspective cohort where all patients routinely received ADM during cleft palate surgery. A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate. |
| Retrospective group | – | –Retrospective cohort of cleft palate patients treated at the same institution and by the same surgeon. These patients received ADM selectively for certain cases (tenuous nasal layer closure, tight oral closure, wide cleft). |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who present to the Montreal Children's Hospital with a cleft palate (Veau II-IV) that undergo surgical repair between the age of 3 months and 3 years.
Key inclusion criteria (1 listed)
- Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.
Key exclusion criteria (4 listed)
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
- Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
- Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
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 |
|---|---|---|
| Acellular Dermal MatrixAlso: DermaMatrix | Device | Prospective group |
Primary outcome
Fistula Formation
Time frame: Within 1 year of surgery
Number of patients who developed post palatoplasty fistula
1 secondary outcome
Number of Participants With Wound Infection
Time frame: Within 1 year of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22743882Aldekhayel SA, Sinno H, Gilardino MS. Acellular dermal matrix in cleft palate repair: an evidence-based review. Plast Reconstr Surg. 2012 Jul;130(1):177-182. doi: 10.1097/PRS.0b013e318254b2dc.
- Individual participant dataSharing planned: No
Related trials for Cleft Palate
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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.
Mirko, S Gilardino, MD principal investigator
Montreal Children's Hospital of the MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by Mirko S. Gilardino at 1 site in Canada.
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 1 inclusion and 4 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 21 Jul 2017. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fistula Formation (time frame: Within 1 year of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867632, which also lists 1 linked publication.
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 21 Jul 2017; AzTrials last refreshed its copy on 27 Oct 2026.