Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Septoplasty

Comparison of the Outcome of Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Patients Undergoing Septoplasty

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

Study Overview

• Status: Active, not recruiting
• Conditions: DNS
• Intervention / Treatment: Procedure: trans-septal quilting suturing; Procedure: intranasal silicone splinting

Detailed Description

With its essential physiological roles, the human nasal cavity has developed over millennia to warm, filter, and humidify breathed air while also promoting olfactory perception and immunological defense. Structural nasal obstruction can result from structural anomalies in the nasal cavity that alter airflow dynamics and raise nasal resistance. The ventilation, temperature control, and humidification processes of the nasal cavity are all negatively impacted by this disease. Numerous studies have demonstrated the positive results of septoplasty, a commonly used surgical procedure for a symptomatic deviated nasal septum. Notably, septoplasty is superior to nonsurgical therapy in reducing nasal obstruction in people with septal deviation, according to a randomized controlled trial.

Although the surgical techniques used in this surgery vary, the deviated cartilage and bony septum that provide a dead area between the mucosal flaps are usually removed. Although they are uncommon, post-operative problems such adhesions, perforation, and septal hematoma and the resulting abscess formation might happen. Three primary strategies have been used to avoid these issues. These include transseptal quilted suturing, intranasal silicon splinting, and intranasal occlusive packing. There is currently no evidence to support the use of intranasal occlusive packing because research has not shown that it affects the incidence of problems during septoplasty. For cartilage support, intranasal silicone splinting is quick, easy to perform, and technically straightforward. However, there is a chance of bacterial colonization and discomfort from frequent sneezing and epiphora. Quilting suture, on the other hand, is more widely accessible and better received by patients. Although it is more time-consuming and technically challenging, it can maintain the remaining cartilage and aid in the repair of mucosal tears.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 60000
      • Sheikh Zayed Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trans-septal quilting suturing	Procedure: trans-septal quilting suturing; 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
Placebo Comparator: intranasal silicone splinting	Procedure: intranasal silicone splinting; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shahida Islam Medical Complex

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2026
• Primary Completion (Estimated): May 3, 2026
• Study Completion (Estimated): June 3, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: septoplasty; quilting; DNS
• Other Study ID Numbers: Sheikh Zayed Hospital Lahore 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No