Cleft PalateNCT03877666
Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
An observational study of Cleft Palate and Cleft Lip and Palate, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement. Read more about this study
- Who is it for?
- Ages 6 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate, Cleft Lip and Palate
- How many people
- 77 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Aug 2020to 12 Mar 2026
- 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 6 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients with orofacial clefts undergoing surgical repair of the deformity.
Who may be able to join
- patients with orofacial clefts, who undergo routine cleft repair
Who cannot join
- missing datasets
- no signed consent for research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.
- Conditions
- Cleft Palate, Cleft Lip and Palate
- Keywords
- cleft lip and palate, cleft palate, palatal microcirculation, tissue oxygenation, surgical technique, anatomy, palatoplasty
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | cleft lip surgery only | |
| medial incision only | Minimal incision group: palatoplasty using medial-only incisions | |
| lateral incision | Lateral incision group: palatoplasty with lateral releasing incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured
The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation.
Measured: One measurement before surgery, one measurement immediately after surgery
Secondary outcomes (2)
Status of wound healing
status of wound healing, fistula formation
Measured: at 3 month and 6 month after surgery
Perioperative Complications
- Intraoperative complications, classified according to the Definition and Classification of Intraoperative Complications (ClassIntra)
- Postoperative complications, graded using the Clavien-Dindo classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start4 Aug 2020
- Primary completion31 Dec 2025
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cleft 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benito K Benitez, MD DDS MHBA, Principal investigator, University Basel and University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877666
- Sponsor's protocol ID
- Microcirculation Palate
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2019
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang MH, Lee ST, Rajendran K. Clinical implications of the velopharyngeal blood supply: a fresh cadaveric study. Plast Reconstr Surg. 1998 Sep;102(3):655-67. doi: 10.1097/00006534-199809030-00007.
PubMed 9727428Mueller AA, Schumann D, Reddy RR, Schwenzer-Zimmerer K, Mueller-Gerbl M, Zeilhofer HF, Sailer HF, Reddy SG. Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair. Plast Reconstr Surg. 2012 Nov;130(5):1120-1130. doi: 10.1097/PRS.0b013e318267d4fb.
PubMed 23096613Woo AS. Evidence-Based Medicine: Cleft Palate. Plast Reconstr Surg. 2017 Jan;139(1):191e-203e. doi: 10.1097/PRS.0000000000002854.
PubMed 28027255
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
- ClinicalTrials.gov ID
- NCT03877666
- Acronym / sponsor ID
- Microcirculation Palate
- Conditions
- Cleft Palate, Cleft Lip and Palate
- Keywords
- cleft lip and palate, cleft palate, palatal microcirculation, tissue oxygenation, surgical technique, anatomy, palatoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 18 Mar 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.
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | –cleft lip surgery only |
| medial incision only | – | –Minimal incision group: palatoplasty using medial-only incisions |
| lateral incision | – | –Lateral incision group: palatoplasty with lateral releasing incisions |
Who may qualify
- Ages
- 6 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients with orofacial clefts undergoing surgical repair of the deformity.
Key inclusion criteria (1 listed)
- patients with orofacial clefts, who undergo routine cleft repair
Key exclusion criteria (2 listed)
- missing datasets
- no signed consent for research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured
Time frame: One measurement before surgery, one measurement immediately after surgery
The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation.
2 secondary outcomes
Status of wound healing
Time frame: at 3 month and 6 month after surgery
Perioperative Complications
Time frame: 6 months
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 17 Mar 2026.
- Background: PubMed 9727428Huang MH, Lee ST, Rajendran K. Clinical implications of the velopharyngeal blood supply: a fresh cadaveric study. Plast Reconstr Surg. 1998 Sep;102(3):655-67. doi: 10.1097/00006534-199809030-00007.
- Background: PubMed 23096613Mueller AA, Schumann D, Reddy RR, Schwenzer-Zimmerer K, Mueller-Gerbl M, Zeilhofer HF, Sailer HF, Reddy SG. Intraoperative vascular anatomy, arterial blood flow velocity, and microcirculation in unilateral and bilateral cleft lip repair. Plast Reconstr Surg. 2012 Nov;130(5):1120-1130. doi: 10.1097/PRS.0b013e318267d4fb.
- Background: PubMed 28027255Woo AS. Evidence-Based Medicine: Cleft Palate. Plast Reconstr Surg. 2017 Jan;139(1):191e-203e. doi: 10.1097/PRS.0000000000002854.
- Individual participant dataSharing planned: Undecided
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.
Benito K Benitez, MD DDS MHBA principal investigator
University 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 Palate and 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 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 17 Mar 2026. 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?
Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured (time frame: One measurement before surgery, one measurement immediately after 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 NCT03877666, which also lists 3 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 17 Mar 2026.