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OpenTrials
Completed

NCT Number: NCT07624643

Outcome of Alar Base Support in Unilateral Secondary Cleft Lip and Nasal Deformity Repair With Dermal Roll Flap

Dermal Roll flap for alar base support

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Key information

Conditions

Cleft Lip Cicatrix Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Flap Design Lip Diseases Mouth Abnormalities Mouth Diseases Nose; Anomaly Pathologic Processes Pathological Conditions, Signs and Symptoms Repair Stomatognathic Diseases Stomatognathic System Abnormalities

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

Background: Unilateral secondary cleft lip and nasal deformity is almost always associated with under projected cleft side alar base for which augmentation with autologous grafts or synthetic material has been described. Many of such cases with secondary cleft lip and nasal deformity require revision surgery for wide lip scar or vermillion disparities. Objective: During lip revision surgery, some vascularized lip tissue can be spared in the area of previous repair and can be utilized as dermal roll flap for augmentation of alar base. Methodology: This prospective study was conducted on forty-three patients requiring lip scar revision with unilateral secondary cleft lip and nasal deformity having difference of alar base projection of 2 to 5mm measured on basal view photograph. Dermal roll flap was marked, de-epithelized and incised. Tunnel under the alar base was made, insetting of flap was done and lip repair completed. Measurements repeated after 6 months to find out improvement in the projection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Secondary cleft lip and nasal deformity with wide lip scar need revision

Exclusion criteria

  • Bilateral cleft lip secondary deformity

Treatment and study plan

Surgery

Procedure

Dermal Roll flap from the lip to support alar base

Primary outcomes

  1. Alar base projection

    Time frame: 6 months

    Pre and post operative alar base projection will be measured by by drawing horizontal line extending from normal alar base towards columella and crossing towards to cleft side alar base making perpendicular to the vertical line passing through the height of columella.

    Difference of cleft side alar base projection will be determined by measuring the distance of alar base central point from the horizontal line.

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Acronym: Dermal Roll

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

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.

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