Deviated Nasal SeptumNCT07860502
Quilting Versus Chain Suture in Septoplasty
A study testing Quilting Suture Technique and Chain Suture Technique in people with Deviated Nasal Septum, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the effectiveness and postoperative outcomes of quilting suture and chain suture techniques in patients undergoing septoplasty for symptomatic deviated nasal septum. The study will include patients older than 15 years undergoing septoplasty. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Deviated Nasal Septum
- What is being tested?
- Quilting Suture Technique and Chain Suture Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Jan 2021to 26 Jan 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged more than 15 years.
- Patients with symptoms of deviated nasal septum causing difficulty in nasal breathing.
- Patients with traumatic and caudal septal dislocation.
Who cannot join
- Patients with other medical conditions such as leprosy, syphilis, tuberculosis, or blood dyscrasias.
- Patients with a history of drug sniffing, such as cocaine use.
- Patients with a previous history of nasal or septal surgery.
- Patients who are unfit for general anesthesia.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
ENT Department Mayo Hospital Lahore
Lahore, Punjab Province, 54950
About this study
Official title: EFFICACY OF QUILTING SUTURE TECHNIQUE AS COMPARED TO CHAIN SUTURE IN PATIENTS UNDERGOING SEPTOPLASTY
The goal of this clinical trial is to compare the effectiveness and postoperative outcomes of quilting suture and chain suture techniques in patients undergoing septoplasty for symptomatic deviated nasal septum. The study will include patients older than 15 years undergoing septoplasty.
The main questions it aims to answer are:
Read more
- Does quilting suture or chain suture result in a shorter suture placement/surgical duration?
- Is there a difference between the two techniques in postoperative pain, bleeding, septal hematoma, and adhesions/synechiae formation?
Researchers will compare patients receiving quilting sutures with patients receiving chain sutures to evaluate differences in surgical duration and postoperative complications. Participants will be randomly assigned to one of the two groups.
Participants will:
- Undergo septoplasty as part of their planned treatment.
- Be randomly assigned to receive either quilting suture or chain suture to close and stabilize the nasal septum.
- Have postoperative pain assessed using a visual analog scale on postoperative days 1, 2, and 3.
- Be assessed for postoperative bleeding and septal hematoma.
- Be examined for adhesions/synechiae on postoperative day 15 and at 1 month.
Read the detailed description
Septoplasty is performed to correct symptomatic deviation of the nasal septum and is one of the commonly performed nasal procedures. During septoplasty, mucoperichondrial and mucoperiosteal flaps are elevated and the deviated portion of the septum is corrected or removed. This may leave a potential space between the septal flaps, which can contribute to postoperative complications such as bleeding and septal hematoma. Septal suturing is used to obliterate this dead space and stabilize the septal flaps.
Quilting suture is a commonly used technique in which a continuous absorbable suture is placed through the septal flaps to provide a quilting effect and stabilize the septum. Chain suture, also described as the Gulhane suture, is a running suture technique in which the suture is passed through the septum and interlooped on the opposite side, producing a chain-like configuration.
This randomized controlled trial is designed to compare these two septal suturing techniques in patients undergoing septoplasty. The study will assess surgical duration and selected postoperative outcomes, including pain, postoperative bleeding, septal hematoma, and adhesions/synechiae. The rationale for the study is that, although both techniques are used for septal stabilization, limited evidence is available regarding their comparative postoperative outcomes, particularly in the local clinical setting.
A total of 84 participants will be enrolled and randomly allocated into two equal groups of 42 participants. Randomization will be performed using a lottery method after confirmation of eligibility and obtaining informed written consent. One group will undergo septal closure using the quilting suture technique, while the other group will undergo closure using the chain suture technique. Septoplasty procedures will be performed by the same surgical team using a Freer's incision. A 3/0 synthetic absorbable Vicryl suture will be used for the respective suturing techniques.
Surgical duration will be recorded from the placement of the first suture to the completion of the last suture. Postoperative pain will be assessed using a visual analog scale on postoperative days 1, 2, and 3. Postoperative bleeding will be recorded after surgery and during the early postoperative period using a predefined grading scale. Septal hematoma will be assessed clinically, while adhesions or synechiae will be evaluated by anterior rhinoscopic examination during follow-up visits. Follow-up assessment for adhesions/synechiae will be performed on the 15th postoperative day and at 1 month.
The collected data will be analyzed using SPSS version 26. Quantitative variables, including age, surgical duration, and pain scores, will be summarized using mean and standard deviation. Categorical variables and postoperative complications will be presented as frequencies and percentages. Appropriate statistical tests will be used to compare outcomes between the two treatment groups, with a P value <0.05 considered statistically significant.
- Conditions
- Deviated Nasal Septum
- Being tested
- Quilting Suture Technique, Chain Suture Technique
- Keywords
- Deviated Nasal Septum Septoplasty Quilting Suture Chain Suture Nasal Septal Suturing Postoperative Pain Postoperative Bleeding Septal Hematoma Synechiae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quilting Suture TechniqueProcedure or surgery
A continuous quilting suture technique used to obliterate the dead space and stabilize the mucoperichondrial flaps following septoplasty. A 3/0 synthetic absorbable Vicryl suture is used.
Chain Suture TechniqueProcedure or surgery
A running chain suture technique in which the suture is passed through the nasal septum and interlooped with itself on the opposite side to stabilize the septal flaps. A 3/0 synthetic absorbable Vicryl suture is used.
| Study group | Role | What they receive |
|---|---|---|
| Quilting Suture | Experimental | Participants in this arm will undergo septoplasty with closure and stabilization of the nasal septal flaps using the quilting suture technique. A 3/0 synthetic absorbable Vicryl continuous single suture will be used. Receives: Procedure: Quilting Suture Technique |
| Chain Suture | Experimental | Participants in this arm will undergo septoplasty with closure and stabilization of the nasal septal flaps using the chain suture technique. A 3/0 synthetic absorbable Vicryl suture will be used. Receives: Procedure: Chain Suture Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Suture Placement
Duration of surgery will be measured in seconds, from the placement of the first suture to the completion of the last suture, and compared between the quilting suture and chain suture groups.
Measured: During the surgical procedure
Secondary outcomes (4)
Postoperative Pain
Postoperative pain will be assessed using the Visual Analog Scale (VAS) and compared between the quilting suture and chain suture groups.
Measured: Postoperative days 1, 2, and 3
Postoperative Bleeding
Postoperative bleeding will be assessed using a predefined bleeding scale, ranging from no bleeding to continuous bleeding requiring repacking, and compared between the two study groups.
Measured: Immediately after surgery and on postoperative days 2 and 3
Septal Hematoma
The presence or absence of postoperative septal hematoma will be assessed clinically and compared between participants receiving quilting suture and those receiving chain suture.
Measured: Postoperative day 1, postoperative day 15, and 1 month
Adhesions/Synechiae Formation
The formation of postoperative nasal adhesions/synechiae will be assessed by anterior rhinoscopic examination and compared between the quilting suture and chain suture groups.
Measured: Postoperative day 15 and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start27 Jan 2021
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deviated Nasal SeptumStudies 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
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Eligible patients undergoing septoplasty will be randomly allocated in a 1:1 ratio to receive either quilting suture or chain suture for septal stabilization. Each participant will remain in the assigned intervention group throughout the study.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniyal Babar, Services Institute of Medical Sciences, Pakistan
- Investigators
- Daniyal Babar, Principal investigator, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860502
- Sponsor's protocol ID
- 23/RC/KEMU
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is being conducted for academic research purposes and individual-level data contain participant information that will not be made publicly available. Only aggregate study results will be reported.
Publications
Yadav K, Ojha T, Gakhar S, Sharma A, Singhal A, Kataria V. Effectiveness of Nasal Packing in Trans-septal Suturing Technique in Septoplasty: A Randomized Comparative Study. Indian J Otolaryngol Head Neck Surg. 2019 Nov;71(Suppl 3):1765-1769. doi: 10.1007/s12070-017-1111-8. Epub 2017 Mar 31.
PubMed 31763241
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF QUILTING SUTURE TECHNIQUE AS COMPARED TO CHAIN SUTURE IN PATIENTS UNDERGOING SEPTOPLASTY
- ClinicalTrials.gov ID
- NCT07860502
- Acronym / sponsor ID
- 23/RC/KEMU
- Conditions
- Deviated Nasal Septum
- Keywords
- Deviated Nasal Septum Septoplasty Quilting Suture Chain Suture Nasal Septal Suturing Postoperative Pain Postoperative Bleeding Septal Hematoma Synechiae
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 6 Oct 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.
The goal of this clinical trial is to compare the effectiveness and postoperative outcomes of quilting suture and chain suture techniques in patients undergoing septoplasty for symptomatic deviated nasal septum. The study will include patients older than 15 years undergoing septoplasty.
The main questions it aims to answer are:
- Does quilting suture or chain suture result in a shorter suture placement/surgical duration?
- Is there a difference between the two techniques in postoperative pain, bleeding, septal hematoma, and adhesions/synechiae formation?
Researchers will compare patients receiving quilting sutures with patients receiving chain sutures to evaluate differences in surgical duration and postoperative complications. Participants will be randomly assigned to one of the two groups.
Participants will:
- Undergo septoplasty as part of their planned treatment.
- Be randomly assigned to receive either quilting suture or chain suture to close and stabilize the nasal septum.
- Have postoperative pain assessed using a visual analog scale on postoperative days 1, 2, and 3.
- Be assessed for postoperative bleeding and septal hematoma.
- Be examined for adhesions/synechiae on postoperative day 15 and at 1 month.
Detailed description
Septoplasty is performed to correct symptomatic deviation of the nasal septum and is one of the commonly performed nasal procedures. During septoplasty, mucoperichondrial and mucoperiosteal flaps are elevated and the deviated portion of the septum is corrected or removed. This may leave a potential space between the septal flaps, which can contribute to postoperative complications such as bleeding and septal hematoma. Septal suturing is used to obliterate this dead space and stabilize the septal flaps.
Quilting suture is a commonly used technique in which a continuous absorbable suture is placed through the septal flaps to provide a quilting effect and stabilize the septum. Chain suture, also described as the Gulhane suture, is a running suture technique in which the suture is passed through the septum and interlooped on the opposite side, producing a chain-like configuration.
This randomized controlled trial is designed to compare these two septal suturing techniques in patients undergoing septoplasty. The study will assess surgical duration and selected postoperative outcomes, including pain, postoperative bleeding, septal hematoma, and adhesions/synechiae. The rationale for the study is that, although both techniques are used for septal stabilization, limited evidence is available regarding their comparative postoperative outcomes, particularly in the local clinical setting.
A total of 84 participants will be enrolled and randomly allocated into two equal groups of 42 participants. Randomization will be performed using a lottery method after confirmation of eligibility and obtaining informed written consent. One group will undergo septal closure using the quilting suture technique, while the other group will undergo closure using the chain suture technique. Septoplasty procedures will be performed by the same surgical team using a Freer's incision. A 3/0 synthetic absorbable Vicryl suture will be used for the respective suturing techniques.
Surgical duration will be recorded from the placement of the first suture to the completion of the last suture. Postoperative pain will be assessed using a visual analog scale on postoperative days 1, 2, and 3. Postoperative bleeding will be recorded after surgery and during the early postoperative period using a predefined grading scale. Septal hematoma will be assessed clinically, while adhesions or synechiae will be evaluated by anterior rhinoscopic examination during follow-up visits. Follow-up assessment for adhesions/synechiae will be performed on the 15th postoperative day and at 1 month.
The collected data will be analyzed using SPSS version 26. Quantitative variables, including age, surgical duration, and pain scores, will be summarized using mean and standard deviation. Categorical variables and postoperative complications will be presented as frequencies and percentages. Appropriate statistical tests will be used to compare outcomes between the two treatment groups, with a P value <0.05 considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Eligible patients undergoing septoplasty will be randomly allocated in a 1:1 ratio to receive either quilting suture or chain suture for septal stabilization. Each participant will remain in the assigned intervention group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Quilting Suture | Experimental | Procedure: Quilting Suture TechniqueParticipants in this arm will undergo septoplasty with closure and stabilization of the nasal septal flaps using the quilting suture technique. A 3/0 synthetic absorbable Vicryl continuous single suture will be used. |
| Chain Suture | Experimental | Procedure: Chain Suture TechniqueParticipants in this arm will undergo septoplasty with closure and stabilization of the nasal septal flaps using the chain suture technique. A 3/0 synthetic absorbable Vicryl suture will be used. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged more than 15 years.
- Patients with symptoms of deviated nasal septum causing difficulty in nasal breathing.
- Patients with traumatic and caudal septal dislocation.
Key exclusion criteria (4 listed)
- Patients with other medical conditions such as leprosy, syphilis, tuberculosis, or blood dyscrasias.
- Patients with a history of drug sniffing, such as cocaine use.
- Patients with a previous history of nasal or septal surgery.
- Patients who are unfit for general anesthesia.
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 |
|---|---|---|
| Quilting Suture TechniqueA continuous quilting suture technique used to obliterate the dead space and stabilize the mucoperichondrial flaps following septoplasty. A 3/0 synthetic absorbable Vicryl suture is used. | Procedure or surgery | Quilting Suture |
| Chain Suture TechniqueA running chain suture technique in which the suture is passed through the nasal septum and interlooped with itself on the opposite side to stabilize the septal flaps. A 3/0 synthetic absorbable Vicryl suture is used. | Procedure or surgery | Chain Suture |
Primary outcome
Duration of Suture Placement
Time frame: During the surgical procedure
Duration of surgery will be measured in seconds, from the placement of the first suture to the completion of the last suture, and compared between the quilting suture and chain suture groups.
4 secondary outcomes
Postoperative Pain
Time frame: Postoperative days 1, 2, and 3
Postoperative Bleeding
Time frame: Immediately after surgery and on postoperative days 2 and 3
Septal Hematoma
Time frame: Postoperative day 1, postoperative day 15, and 1 month
Adhesions/Synechiae Formation
Time frame: Postoperative day 15 and 1 month
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 6 Oct 2026.
- Background: PubMed 31763241Yadav K, Ojha T, Gakhar S, Sharma A, Singhal A, Kataria V. Effectiveness of Nasal Packing in Trans-septal Suturing Technique in Septoplasty: A Randomized Comparative Study. Indian J Otolaryngol Head Neck Surg. 2019 Nov;71(Suppl 3):1765-1769. doi: 10.1007/s12070-017-1111-8. Epub 2017 Mar 31.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is being conducted for academic research purposes and individual-level data contain participant information that will not be made publicly available. Only aggregate study results will be reported.
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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.
Daniyal Babar principal investigator
Services Institute of Medical Sciences, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quilting Suture Technique and Chain Suture Technique in people with Deviated Nasal Septum, run by Services Institute of Medical Sciences, Pakistan 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 3 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 6 Oct 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. 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?
Duration of Suture Placement (time frame: During the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07860502, which also lists 1 linked publication.
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 6 Oct 2026.