Unilateral Cleft Repair in One Surgery With Pure Primary Healing

Completed

• Conditions: Cleft Lip and Palate

• Registration Number: NCT04108416
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Status Verified: 2019-09
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cleft size measurement	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 Outcome Measures

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

Trial Locations

Locations (1)

Universitätsspital Basel; 🇨🇭 Basel, Switzerland