Unilateral Cleft Repair in One Surgery With Pure Primary Healing

September 27, 2019 updated by: Benito Benitez, University Hospital, Basel, Switzerland
Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

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, Switzerland, 4310
        • Universitatsspital 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

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

newborn patients with complete unilateral cleft lip and palate treated at the University Hospital Basel in Switzerland

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured on a model after birth and at surgery with 8 month of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 1, 3 and 6 month after surgery
Full primary healing of the former cleft, no fistula formation, no oronasal leaking
1, 3 and 6 month after surgery
Adverse events
Time Frame: 6 month
Surgical and anaesthesia-relate adverse events
6 month

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Benitez Benito, MD DMD, University of 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)

January 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PurePrimary

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

without further approval by our ethical commission individual participant data is not available to other researchers

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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