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Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04108416
Enrollment
11
Registered
2019-09-30
Start date
2014-01-01
Completion date
2019-06-30
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

cleft lip, cleft palate, cleft lip and palate, orofacial cleft

Brief summary

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

Interventions

PROCEDURECleft 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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cleft size measurementMeasured on a model after birth and at surgery with 8 month of ageCleft size is measured before and after passive palatal plate therapy

Secondary

MeasureTime frameDescription
Wound healing1, 3 and 6 month after surgeryFull primary healing of the former cleft, no fistula formation, no oronasal leaking
Adverse events6 monthSurgical and anaesthesia-relate adverse events

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026