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Clinical Trials/NCT04108416
NCT04108416CompletedNot Applicable

Unilateral Cleft Repair in One Surgery With Pure Primary Healing

University Hospital, Basel, Switzerland1 site in 1 country11 target enrollmentStarted: January 1, 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
11
Locations
1
Primary Endpoint
Cleft size measurement
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 2 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

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

Benito Benitez

Principal Investigator

University Hospital, Basel, Switzerland

Study Sites (1)

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