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Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose in children following unilateral cleft lip repair? The researchers will compare the use and non-use of a customized nostril retainer to determine whether the retainer is effective in supporting the aesthetic reconstruction of the nose. Participants will be divided into two groups (the intervention group and the control group): Study population: Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair. Intervention group: Participants who use a customized nostril retainer after unilateral cleft lip repair. Control group: Participants who do not use a customized nostril retainer after unilateral cleft lip repair. Follow-up: Participants will return for follow-up visits at 1 week, 3 months, and 6 months after surgery. Outcome assessment: Nasal aesthetics will be evaluated at each follow-up visit, along with the convenience and ease of use of the retainer, assessed through interviews with caregivers.
Trial Details
NCT Number NCT07850180
Lead Sponsor Hanoi Medical University
Conditions
(from sponsor)		 Unilateral Cleft Lip
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov