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Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04616690
Collaborator
Institute of Mother and Child, Warsaw, Poland (Other)
40
Enrollment
1
Location
23.8
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective observational cohort study of consecutive patients with cleft lip and palate deformity undergoing cleft repair at the Institute of Mother and Child in Warsaw. Cleft morphology will be captured with photo and intraoral camera before routine surgery at around 8 months. Furthermore, wound healing at 3 months postoperative will be assessed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collaborative, Comparative Study on Three-dimensional Cleft Lip and Palate Morphology Prior to One-stage Cleft Repair (Warsaw/Basel)
    Actual Study Start Date :
    Dec 7, 2020
    Actual Primary Completion Date :
    May 17, 2022
    Anticipated Study Completion Date :
    Nov 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. True Cleft Area in mm2 of Newborns With Cleft Lip and Palate at 8 Month of Age [Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.]

      True cleft area in mm2 will be measured at 8 month of age in newborns with cleft lip and palate.

    Secondary Outcome Measures

    1. Cleft Width and Height in mm of Newborns With Cleft Lip and Palate at 8 Month of Age [Capture of the cleft morphology with photo and intraoral camera before routine surgery at around 8 months.]

      Measurement of the width and height in mm of the cleft measured at 8 months of age.

    2. Wound Healing (fistula yes or no) 3 Months After One-Stage Cleft Repair [At 3 months postoperative]

      Assessment of wound healing by fistula formation at 3 months postoperative

    3. Correlation of Cleft Width in mm and Wound Healing after One-Stage Cleft Repair [At surgery and at 3 months postoperative]

      Evaluation of the correlation between cleft width in mm and wound healing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 15 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients with orofacial cleft, who undergo routine cleft repair
    Exclusion Criteria:

    • missing datasets

    • no signed consent for research

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institute of Mother and Child Warsaw Poland 01-211

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland
    • Institute of Mother and Child, Warsaw, Poland

    Investigators

    • Principal Investigator: Benito K Benitez, MD DMD, University and University Hospital of Basel
    • Principal Investigator: Andrzej Brudnicki, MD DDS PhD, Maxillo-facial Surgery Unit, Pediatric Surgery Clinic, Institute of Mother and Child

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Benito Benitez, Principal Investigator, University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT04616690
    Other Study ID Numbers:
    • Warsaw/Basel
    • ch20Benitez
    First Posted:
    Nov 5, 2020
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Benito Benitez, Principal Investigator, University Hospital, Basel, Switzerland
    Cleft Lip and Palate
    Presurgical Orthopedics
    Cleft Morphology
    Palatal Plate
    Additional relevant MeSH terms:
    Cleft Palate
    Cleft Lip

    Study Results

    No Results Posted as of May 18, 2022