ClinicalTrials.gg
CompletedNCT07537920Updated Jul 1, 2026

Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Septoplasty

An interventional study of trans-septal quilting suturing and intranasal silicone splinting in DNS, sponsored by Shahida Islam Medical Complex. Completed at 1 site in Pakistan. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Shahida Islam Medical Complex · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
10 Years to 40 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • DNS

Keywords

  • DNS
  • septoplasty
  • quilting
03

In context

Lead sponsor

Shahida Islam Medical Complex is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who have had nasal surgery in the past.
  • Individuals who suffer from bleeding disorders ( >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/ levels greater than 1.0 mg/dl
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    trans-septal quilting suturing

    Procedure: trans-septal quilting suturing

  • Placebo comparator
    intranasal silicone splinting

    Procedure: intranasal silicone splinting

Interventions

  • Proceduretrans-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

  • Procedureintranasal 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 48 hours

  2. 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

    Time frame: 4 weeks

07

Study locations

1 site
  • Sheikh Zayed Hospital
    Lahore, Punjab Province 60000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07537920
Lead sponsor
Shahida Islam Medical Complex
Responsible party
Dr Mudassar Saeed Pansota (Associate Professor, Shahida Islam Medical Complex) — Principal investigator
First posted
Apr 17, 2026
Start date
Mar 4, 2026
Primary completion
May 3, 2026
Completion
Jun 3, 2026
Last update
Jul 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion