Transverse Facial Cleft Repair Using Precise Location of Commissure

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

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

Study Overview

• Status: Completed
• Conditions: Transverse Facial Cleft
• Intervention / Treatment: Procedure: precise location of commissure

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 Type: Observational
• Enrollment (Actual): 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with transverse facial cleft who hadn't receive any treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
redesigned; 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
classical; 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?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: S-K338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No