Transverse Facial Cleft Repair Using Precise Location of Commissure

Completed

• Conditions: Transverse Facial Cleft
• Interventions: Procedure: precise location of commissure

• Registration Number: NCT03282721
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

Detailed Description

Nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. The main outcome measurement included scar, symmetry of the commissure. They were graded in five scores by five resident physicians who had never seen the patients. The results were compared with healthy controls.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2016-01-30
• Study Completion: 2016-12-30
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Clinical diagnosis of transverse facial cleft disease;
• Must not received any lip surgeries before;
• Such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate.

Exclusion Criteria

• Severe general diseases;
• Patients who had been treated with lip surgery;
• Patients and/or his/her family didn't want to continue the clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
redesigned	precise location of commissure	the commissure constructions of the cleft side were precised located, include the upper and lower inherent vermilion border, the interior commissure, the outline of commissure, the exterior commissure, the upper skin-mucosa junction and the lower skin-mucosa junction.

Primary Outcome Measures

Name	Time	Method
symmetry of the commissures	6 to 12 months after surgery	symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.
Scar of the repaired commissures	6 to 12 months after surgery	scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.

Secondary Outcome Measures

Name	Time	Method
scar of the repaired commissures	1 to 6 months after surgery	scar of the repaired commissure was graded in five points. They were scored by five resident physicians who had never seen the patients.
symmetry of the commissures	1 to 6 months after surgery	symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.