Outcomes Assessment of Septal Extension Graft Versus Columellar Strut Graft in Rhinoplasty.

NCT ID: NCT06958575

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-07-01

Brief Summary

Nose is an important aesthetic landmark with its length, width, shape, and position in the middle of the face. Rhinoplasty is now one of the most common rhinological procedures with both functional and aesthetic aspects. Tip plasty is considered the core of rhinoplasty. The interaction among lower lateral cartilages, septal cartilage, adjacent soft tissues, tissue dynamics, and surgical techniques determines the nasal tips projection, rotation, and overall shape. Various graft sources and types were used for tip support in rhinoplasty such as columellar struts, septal extensions, and cap grafts.

The columellar strut graft, first introduced in 1932, has became a widely adopted technique. Typically a cartilage graft is positioned between the medial crura to provide support and stability to the nasal tip. Recent studies reported some drawbacks of columellar strut such as widening the columella and resorption or displacement of the graft due to their lack of attachment to the caudal septum. Septal extension grafts extend from the caudal edge of the nasal septum into the lower lateral cartilages, these grafts offer crucial structural support to the nasal tip. Despite of their the wide use of columellar strut and septal extention graft, limited studies compared their results.

Conditions

Septal Extension Graft in Rhinoplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal extension grafts.

Group Type: EXPERIMENTAL

Septal extension graft

Intervention Type: PROCEDURE

Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal graft.

Group 2

Columellar strut graft will be used. A strut graft 10-12 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.

Group Type: ACTIVE_COMPARATOR

Columellar strut

Intervention Type: PROCEDURE

Columellar strut graft will be used. A strut graft 1012 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.

Interventions

Septal extension graft

Septal extension graft will be used. The triangle-shaped cartilage graft prepared from the septal cartilage is placed into one or bothsides of the caudal septum reciprocally according to its structure and curvature and sutured with horizontal mattress sutures. After graft stabilization, two insulin needles are passed through the medial crura and the graft to determine its level of placement. After the rotation and nasal projection are adjusted, the medial crura are sutured to the septal graft.

Intervention Type: PROCEDURE

Columellar strut

Columellar strut graft will be used. A strut graft 1012 mm long is placed into a web created between the two medial crura and stabilized by sutures placed between the graft and medial crura.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adult patient (more than 18 years).

2. Patients with any type of tip deformaties.

3. Patients fit for surgery.

Exclusion Criteria

1. Patients with history of previous nasal surgery.

2. Pregnant patients.

3. Patients with chronic diseases affecting wound healing e.g. DM and blood diseases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hossam Aldein Samir Abd Elazeem Mohammed

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hossam Aldein Mohammed

Role: CONTACT

Hosam.20133977@med.au.edu.eg

+201019858519

Other Identifiers

septal extension graf

Identifier Type: -

Identifier Source: org_study_id