Cleft Lip and PalateNCT04108416
Unilateral Cleft Repair in One Surgery With Pure Primary Healing
An observational study of Cleft Lip and Palate, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Cleft lip and palate repair
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2014to 30 Jun 2019
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland
Who may be able to join
- newborn patients with complete unilateral cleft lip and palate
Who cannot join
- with associated syndrome
- previous lip/ palate repair
- previous presurgical orthopaedics other than passive palatal plate
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre
- Conditions
- Cleft Lip and Palate
- Being tested
- Cleft lip and palate repair
- Keywords
- cleft lip, cleft palate, cleft lip and palate, orofacial cleft
- 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.
Cleft lip and palate repairProcedure or surgery
The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleft size measurement
Cleft size is measured before and after passive palatal plate therapy
Measured: Measured on a model after birth and at surgery with 8 month of age
Secondary outcomes (2)
Wound healing
Full primary healing of the former cleft, no fistula formation, no oronasal leaking
Measured: 1, 3 and 6 month after surgery
Adverse events
Surgical and anaesthesia-relate adverse events
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benito Benitez, University Hospital, Basel, Switzerland
- Investigators
- Benitez Benito, MD DMD, Principal investigator, University of Basel and University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108416
- Sponsor's protocol ID
- PurePrimary
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: without further approval by our ethical commission individual participant data is not available to other researchers
Publications
Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available.
PubMed 4873510Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23.
PubMed 15861051Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1.
PubMed 22551772Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1.
PubMed 16526922Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3.
PubMed 34896005
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Cleft Repair in One Surgery With Pure Primary Healing
- ClinicalTrials.gov ID
- NCT04108416
- Acronym / sponsor ID
- PurePrimary
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft lip, cleft palate, cleft lip and palate, orofacial cleft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 30 Sep 2019 (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.
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland
Key inclusion criteria (1 listed)
- newborn patients with complete unilateral cleft lip and palate
Key exclusion criteria (3 listed)
- with associated syndrome
- previous lip/ palate repair
- previous presurgical orthopaedics other than passive palatal plate
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 |
|---|---|---|
| Cleft lip and palate repairThe intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel | Procedure or surgery | – |
Primary outcome
Cleft size measurement
Time frame: Measured on a model after birth and at surgery with 8 month of age
Cleft size is measured before and after passive palatal plate therapy
2 secondary outcomes
Wound healing
Time frame: 1, 3 and 6 month after surgery
Adverse events
Time frame: 6 month
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 1 Oct 2019.
- Background: PubMed 4873510Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available.
- Background: PubMed 15861051Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23.
- Background: PubMed 22551772Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1.
- Background: PubMed 16526922Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1.
- Derived from this study: PubMed 34896005Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3.
- Individual participant dataSharing planned: No. without further approval by our ethical commission individual participant data is not available to other researchers
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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.
Benitez Benito, MD DMD principal investigator
University of Basel and University Hospital Basel
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 Lip and Palate, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 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 1 Oct 2019. 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 Switzerland. 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?
Cleft size measurement (time frame: Measured on a model after birth and at surgery with 8 month of age). 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 NCT04108416, which also lists 5 linked publications.
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 1 Oct 2019.