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Transverse Facial Cleft Repair Using Precise Location of Commissure

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ClinicalTrials.gov Identifier: NCT03282721
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Lian Zhou, Peking Union Medical College Hospital

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

Condition or disease Intervention/treatment
Transverse Facial Cleft 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 nine patients treated with classical transverse facial cleft repair, and eight patients seen in our clinic other than transverse facial cleft.

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Short/Long-term Observation of Transverse Facial Cleft Repair Using Precise Location of Commissure
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : January 30, 2016
Actual Study Completion Date : December 30, 2016

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.



Primary Outcome Measures :
  1. Scar of the repaired commissures [ Time Frame: 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.

  2. symmetry of the commissures [ Time Frame: 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.


Secondary Outcome Measures :
  1. scar of the repaired commissures [ Time Frame: immediately 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.

  2. symmetry of the commissures [ Time Frame: immediately after surgery ]
    symmetry of the commissures was graded in five points. They were scored by five resident physicians who had never seen the patients.

  3. scar of the repaired commissures [ Time Frame: 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.

  4. symmetry of the commissures [ Time Frame: 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.



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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with transverse facial cleft who hadn't receive any treatment.
Criteria

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.

Responsible Party: Lian Zhou, Prof., Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03282721     History of Changes
Other Study ID Numbers: S-K338
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes