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Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty

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ClinicalTrials.gov Identifier: NCT03047499
Recruitment Status : Unknown
Verified February 2017 by Mostafa Khairy, Cairo University.
Recruitment status was:  Recruiting
First Posted : February 9, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Mostafa Khairy, Cairo University

Study Description
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Brief Summary:
Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty

Condition or disease Intervention/treatment
Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair Drug: Botulinum toxin type A

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty
Estimated Study Start Date : February 15, 2017
Estimated Primary Completion Date : October 15, 2017
Estimated Study Completion Date : November 15, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Scar Length Drug: Botulinum toxin type A
Botulinum toxin type-A injection
Vancouver scar scale Drug: Botulinum toxin type A
Botulinum toxin type-A injection
Scar width Drug: Botulinum toxin type A
Botulinum toxin type-A injection


Outcome Measures
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Primary Outcome Measures :
  1. Scar Length [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children up to 6 months
Criteria

Inclusion Criteria:

  • Primary cleft lip

Exclusion Criteria:

  • Cleft palate
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047499


Contacts
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Contact: Mostafa Ayman Khairy 00201001155527 mostafakhairy100@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 72427
Contact: Rehab Tariq Elsharkawy, Dr         
Sponsors and Collaborators
Mostafa Khairy
More Information
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Additional Information:

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Responsible Party: Mostafa Khairy, Cairo University
ClinicalTrials.gov Identifier: NCT03047499    
Other Study ID Numbers: CEBC-CU-2017-02-04
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents