Transverse Facial Cleft Repair Using Precise Location of Commissure

Transverse Facial Cleft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282721
• Other study ID #: S-K338
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 30, 2016

Study information

• Verified date: September 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 30, 2016
• Est. primary completion date: January 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facies
• Transverse Facial Cleft

Intervention

Procedure:
• precise location of commissure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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