Unilateral Cleft Repair in One Surgery With Pure Primary Healing

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

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel

Basel, 4310, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cleft lip and palate repair

Procedure

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

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

Time frame: 1, 3 and 6 month after surgery

Full primary healing of the former cleft, no fistula formation, no oronasal leaking
Adverse events

Time frame: 6 month

Surgical and anaesthesia-relate adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2019
First posted: Sep 30, 2019
Registry last updated: Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed