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CompletedNCT07624643Dermal RollUpdated Jun 3, 2026

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

An interventional study of surgery in Cleft Lip, Nose; Anomaly and Repair, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Oct 2023, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Sex
All
01

Study summary

Dermal Roll flap for alar base support

Read the detailed description

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.

02

Conditions studied

  • Cleft Lip
  • Nose; Anomaly
  • Repair
  • Flap Design

Keywords

  • Secondary Cleft Lip,
  • Scar,
  • Hypoplasia,
  • Alar Base Projection,
  • Dermal Roll Flap
03

In context

Cleft Lip

162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's enrollment of 45 is above the median of 30 across 114 interventional studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

King Edward Medical University is the lead sponsor of 78 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Bilateral cleft lip secondary deformity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Secondary cleft lip and nasal deformity

    Patients with Secondary cleft lip and nasal deformity

    Procedure: surgery

Interventions

  • Proceduresurgery

    Dermal Roll flap from the lip to support alar base

06

What researchers measure

Primary outcomes

  1. Alar base projection

    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.

    Time frame: 6 months

07

Study locations

1 site
  • King Edward Medical University Lahore
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Publications

  • Farina R, Lolas J, Moreno E, Alister JP, Uribe MF, Pantoja R, Valladares S, Arrue C. Cleft Lip and Palate Midfacial Hypoplasia: Criteria to Choose the Treatment. J Craniofac Surg. 2022 Mar-Apr 01;33(2):496-501. doi: 10.1097/SCS.0000000000007973. PubMed 34261964 ↗

Study documents

  • Protocol and statistical analysis plan · Aug 22, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07624643
Lead sponsor
King Edward Medical University
Responsible party
Afzaal Bajwa (Assistant Professor, King Edward Medical University) — Principal investigator
First posted
Jun 3, 2026
Start date
Oct 1, 2023
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024
Last update
Jun 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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