Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Septoplasty

NCT07537920 | Active Not Recruiting

• 1 other identifier: Sheikh Zayed Hospital Lahore 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There is currently little data comparing intranasal silicone splinting versus trans-septal quilted suturing in terms of preventing problems following septoplasty. The purpose of this study is to compare the results of intranasal silicone splinting with trans-septal quilted suturing following septoplasty. After septoplasty, this study will give us a better procedure with fewer adverse effects. Based on the outcomes, this can then regularly be used that specific approach in general practice to treat these specific individuals in an effort to lower their morbidity

Conditions

DNS

Keywords

DNS; septoplasty; quilting

Outcome Measures

Primary Outcomes (2)

• Mean post-operative pain

  The visual analogue sacle will measure it during the first week, with 0 denoting no discomfort and 10 denoting the worst pain

  48 hours

• Rate of septal hematoma

  A accumulation of blood between the cartilage and the bony nasal septum is known as a nasal septal hematoma, and it was considered positive if blood was seen when the needle was aspirated

  4 weeks

Study Arms (2)

trans-septal quilting suturing

EXPERIMENTAL

Procedure: trans-septal quilting suturing

intranasal silicone splinting

PLACEBO COMPARATOR

Procedure: intranasal silicone splinting

Interventions

trans-septal quilting suturing PROCEDURE

The dead space in group A will be closed using a 3-0 vicryl and a curved cutting needle. The suture was first positioned at the posterior end of the septum under endoscopic view, and a knot will be tied at the distal end of the suture material. After that, the process continued continuously from inferior to superior side-to-side in a zigzag pattern until the caudal end of the septum was reached. The suture will then be tied on itself, usually on the side opposite the first knot

trans-septal quilting suturing

intranasal silicone splinting PROCEDURE

a 2-0 silk mattress suture will be used to secure a 1 mm flat silicone splint that has been covered with fucidin ointment intranasally and bilaterally around the septum at the caudal end. Every patient will be monitored for a week, during which time any post-operative pain and any septal hematomas as defined by the procedure will be recorded. Following surgery, synachiae will be evaluated four weeks later

intranasal silicone splinting

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients between the ages of 10 and 40 who are having septoplasty for a symptomatic nasal septum deviation identified by anterior rhinoscopy;

You may not qualify if:

• Patients who have had nasal surgery in the past.
• Individuals who suffer from bleeding disorders (INR \>1.2).
• Individuals with co-occurring disorders such as hypertension and diabetes mellitus (based on medical records and history).
• Individuals with chronic liver disease, as determined by history and s/bilirubin levels greater than 1.0 mg/dl

Sponsors & Collaborators

• Shahida Islam Medical Complex: lead

Study Sites (1)

Sheikh Zayed Hospital

Lahore, Punjab Province, 60000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: March 4, 2026
• Primary Completion: May 3, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

PA (1)