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OpenTrials
Completed

NCT Number: NCT03282721

Transverse Facial Cleft Repair Using Precise Location of Commissure

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

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Key information

Conditions

Transverse Facial Cleft

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

precise location of commissure

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2017
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.