NCT07537920

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shahida Islam Medical Complex · Academic / Other
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Not accepted

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, we can then regularly use that specific approach in our general practice to treat these specific individuals in an effort to lower their morbidity

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.1 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.2 Numerous studies have demonstrated the positive results of septoplasty, a commonly used surgical procedure for a symptomatic deviated nasal septum.3 Notably, septoplasty is superior to nonsurgical therapy in reducing nasal obstruction in people with septal deviation, according to a randomized controlled trial conducted by van Egmond et al.4 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.5,6 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.6 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

Conditions

• DNS

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2026-03-04
• Primary completion: 2026-05-03
• Completion: 2026-06-03
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Pakistan