DNSNCT07537920
Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Septoplasty
A study testing trans-septal quilting suturing and intranasal silicone splinting in people with DNS, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- DNS
- What is being tested?
- trans-septal quilting suturing and intranasal silicone splinting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2026to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients between the ages of 10 and 40 who are having septoplasty for a symptomatic nasal septum deviation identified by anterior rhinoscopy;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- DNS
- Being tested
- trans-septal quilting suturing, intranasal silicone splinting
- Keywords
- DNS, septoplasty, quilting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-septal quilting suturingProcedure or surgery
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
intranasal silicone splintingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| trans-septal quilting suturing | Experimental | Not described Receives: Procedure: trans-septal quilting suturing |
| intranasal silicone splinting | Placebo comparator | Not described Receives: Procedure: intranasal silicone splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start4 Mar 2026
- Primary completion3 May 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537920
- Sponsor's protocol ID
- Sheikh Zayed Hospital Lahore 2
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Outcome of Trans-septal Quilting Suturing vs Intranasal Silicone Splinting in Patients Undergoing Septoplasty
- ClinicalTrials.gov ID
- NCT07537920
- Acronym / sponsor ID
- Sheikh Zayed Hospital Lahore 2
- Conditions
- DNS
- Keywords
- DNS, septoplasty, quilting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 3 May 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trans-septal quilting suturing | Experimental | Procedure: trans-septal quilting suturing |
| intranasal silicone splinting | Placebo comparator | Procedure: intranasal silicone splinting |
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients between the ages of 10 and 40 who are having septoplasty for a symptomatic nasal septum deviation identified by anterior rhinoscopy;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trans-septal quilting suturingThe 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 or surgery | trans-septal quilting suturing |
| intranasal silicone splintinga 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 | Procedure or surgery | intranasal silicone splinting |
Primary outcome
Mean post-operative pain
Time frame: 48 hours
The visual analogue sacle will measure it during the first week, with 0 denoting no discomfort and 10 denoting the worst pain
Rate of septal hematoma
Time frame: 4 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-septal quilting suturing and intranasal silicone splinting in people with DNS, run by Shahida Islam Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean post-operative pain (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.