NCT07624643

Brief Summary

Dermal Roll flap for alar base support

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 3, 2026

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

May 18, 2026

Last Update Submit

June 1, 2026

Conditions

Cleft LipNose; AnomalyRepairFlap Design

Keywords

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

Outcome Measures

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.

    6 months

Study Arms (1)

Secondary cleft lip and nasal deformity

EXPERIMENTAL

Patients with Secondary cleft lip and nasal deformity

Procedure: surgery

Interventions

surgeryPROCEDURE

Dermal Roll flap from the lip to support alar base

Secondary cleft lip and nasal deformity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Bilateral cleft lip secondary deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 34261964BACKGROUND

MeSH Terms

Conditions

Cleft LipCongenital AbnormalitiesCicatrix

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 3, 2026

Study Start

October 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)