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Clinical Trials/NCT04108416
NCT04108416
Completed
Not Applicable

Unilateral Cleft Repair in One Surgery With Pure Primary Healing

University Hospital, Basel, Switzerland1 site in 1 country11 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip and Palate
Sponsor
University Hospital, Basel, Switzerland
Enrollment
11
Locations
1
Primary Endpoint
Cleft size measurement
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
June 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Principal Investigator
Principal Investigator

Benito Benitez

Principal Investigator

University Hospital, Basel, Switzerland

Eligibility Criteria

Inclusion Criteria

  • newborn patients with complete unilateral cleft lip and palate

Exclusion Criteria

  • with associated syndrome
  • previous lip/ palate repair
  • previous presurgical orthopaedics other than passive palatal plate

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Wound healing(1, 3 and 6 month after surgery)
  • Adverse events(6 month)

Study Sites (1)

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