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NCT04108416 Clinical Trial

Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Cleft Lip and Palate Clinical Trial

Official title:
Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04108416
Other study ID # PurePrimary
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date June 30, 2019

Study information
Verified date September 2019
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date June 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cleft lip and palate repair
The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel

Locations
Country Name City State
Switzerland Universitätsspital Basel Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. — View Citation

Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. Erratum in: Plast Reconstr Surg. 2005 Jul;116(1):361. — View Citation

Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. — View Citation

Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cleft size measurement 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 Wound healing Full primary healing of the former cleft, no fistula formation, no oronasal leaking 1, 3 and 6 month after surgery
Secondary Adverse events Surgical and anaesthesia-relate adverse events 6 month
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