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.
Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.
No local infection or inflammation.
No associated congenital anomalies other than cleft lip and/or cleft palate.
Participants who do not meet any one of the inclusion criteria.
Patients who are unable to attend follow-up visits.
Families or legal guardians who refuse to participate in the study.
Parallel
customized nostril retainer
DeviceParticipants will undergo unilateral cleft lip repair and will then be assigned to either receive or not receive a customized nostril retainer.
Post-intervention nasal symmetry
Columellar deviation: This measure is assessed by the angle formed between the tangent line passing through the nasal base and the line passing through the midpoint of the columella. The value ranges from 0° to 90°, with a larger angle indicating a better outcome. Degree of alar collapse on the affected side compared with the unaffected side: This measure is assessed as the ratio of the alar height on the affected side to the alar height on the unaffected side. The value ranges from 0% to 100%, with a higher ratio indicating a better outcome.
convenience and ease of use of the retainer
Adverse effects: This variable determines the presence or absence of adverse effects associated with the use of the device (e.g., whether the child is irritable or fussy, and whether there is redness or an inflammatory reaction at the device-skin contact area). Convenience and satisfaction: Scores are rated on a 1-5 scale, corresponding to very dissatisfied - dissatisfied - neutral - satisfied - very satisfied, respectively. A higher score indicates greater convenience and satisfaction.
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This trial is not recruiting at the moment. You can still explore other options:
