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

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ClinicalTrials.gov Identifier: NCT03877666
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.

Condition or disease
Cleft Palate Cleft Lip and Palate

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Status of wound healing [ Time Frame: at 3 month and 6 month after surgery ]
    status of wound healing, fistula formation


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with orofacial clefts undergoing surgical repair of the deformity.
Criteria

Inclusion Criteria:

  • patients with orofacial clefts, who undergo routine cleft repair

Exclusion Criteria:

  • missing datasets
  • no signed consent for research.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877666


Contacts
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Contact: Benito K Benitez, MD DDS MHBA 615565285 ext 0041 benito.benitez@usb.ch
Contact: Andreas A Mueller, MD DDS PhD 613286095 ext 0041 andreas.mueller@usb.ch

Locations
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Switzerland
Universitätsspital Basel Recruiting
Basel, Switzerland, 4310
Contact: Benito K Benitez, MD, DDS    615565285 ext 0041    benito.benitez@usb.ch   
Contact: Andreas A Mueller, MD, DDS, PhD    13286095 ext 0041    andreas.mueller@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Benito K Benitez, MD DDS MHBA University Basel and University Hospital Basel
More Information
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Publications:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03877666    
Other Study ID Numbers: Microcirculation Palate
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
 Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities