Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

March 13, 2026 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel
      • Basel, Basel, Switzerland, 4310
        • Universitätsspital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with orofacial clefts undergoing surgical repair of the deformity.

Description

Inclusion Criteria:

  • patients with orofacial clefts, who undergo routine cleft repair

Exclusion Criteria:

  • missing datasets
  • no signed consent for research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One measurement before surgery, one measurement immediately after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of wound healing
Time Frame: at 3 month and 6 month after surgery
status of wound healing, fistula formation
at 3 month and 6 month after surgery
Perioperative Complications
Time Frame: 6 months
  • Intraoperative complications, classified according to the Definition and Classification of Intraoperative Complications (ClassIntra)
  • Postoperative complications, graded using the Clavien-Dindo classification
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Benito K Benitez, MD DDS MHBA, University Basel and University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

March 12, 2026

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Microcirculation Palate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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