Transverse Facial Cleft Repair Using Precise Location of Commissure

Study Overview
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Brief Summary
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To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

Detailed Description
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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.

Official Title
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Transverse Facial Cleft (Macrostomia) Repair: Modification of a Traditional Technique

Conditions
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Transverse Facial Cleft

Intervention / Treatment
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* Procedure: precise location of commissure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| redesigned<br>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. | Procedure: precise location of commissure<br> <br> |
| classical<br>follows the simple-symmetry rule, the commissure of the healthy side is measured, and then the affected side is located accordingly. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar of the repaired commissures | scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients. | 6 to 12 months after surgery | 
| symmetry of the commissures | symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients. | 6 to 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar of the repaired commissures | scar of the repaired commissures was graded in five points. They were scored by five resident physicians who had never seen the patients. | immediately after surgery | 
| symmetry of the commissures | symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients. | immediately after surgery | 
| scar of the repaired commissures | scar of the repaired commissure was graded in five points. They were scored by five resident physicians who had never seen the patients. | 1 to 6 months after surgery | 
| symmetry of the commissures | symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients. | 1 to 6 months after surgery |