Nasal Septal DeviationNCT07919496
Antibacterial (Triclosan-Coated) Versus Conventional Sutures in Septoplasty
A study testing Triclosan-Coated Polyglactin 910 Suture and Conventional Polyglactin 910 Suture in people with Nasal Septal Deviation and Surgical Wound Healing, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether an antibacterial (triclosan-coated) suture improves healing after septoplasty in adults, compared with a conventional suture of the same material. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Septal Deviation, Surgical Wound Healing, Surgical Site Infection
- What is being tested?
- Triclosan-Coated Polyglactin 910 Suture and Conventional Polyglactin 910 Suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Dec 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Scheduled for elective septoplasty for nasal septal deviation
- American Society of Anesthesiologists (ASA) physical status I or II
- Voluntary participation with written informed consent
- Able to communicate, understand and respond in Turkish
- No hearing or speech impairment severe enough to interfere with the assessments
Who cannot join
- Age younger than 18 or older than 65 years
- Cognitive impairment precluding interviews, or inability to cooperate
- Uncontrolled systemic disease
- Immunosuppression
- Active local or systemic infection before surgery
- Major postoperative complication preventing continued follow-up
- Inability to attend the day 7 and day 21 follow-up visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital, Department of Otorhinolaryngology
Sakarya, 54100
About this study
Official title: Effects of Triclosan-Coated Versus Conventional Polyglactin 910 Sutures on Postoperative Mucosal Healing, Infection, Pain and Patient Comfort After Septoplasty: A Prospective, Randomized, Controlled Trial
The goal of this clinical trial is to learn whether an antibacterial (triclosan-coated) suture improves healing after septoplasty in adults, compared with a conventional suture of the same material. The main questions it aims to answer are:
- Does the triclosan-coated suture improve healing of the nasal lining and reduce signs of infection on days 7 and 21 after surgery?
- Does it reduce pain and improve comfort after surgery?
Read more
Researchers compared triclosan-coated polyglactin 910 sutures (Coated VICRYL Plus Antibacterial) with uncoated polyglactin 910 sutures (Coated VICRYL) to see whether the antibacterial coating affects healing, infection, pain and comfort.
Participants:
- Underwent elective septoplasty and were randomly assigned to one of the two suture types, without knowing which one was used
- Attended follow-up visits on days 7 and 21 after surgery, where the nose was examined with an endoscope by an examiner who did not know the suture type
- Rated their pain, nasal blockage and comfort at the same visits
Read the detailed description
Design and setting: Single-centre, prospective, randomized, controlled, parallel-group trial conducted in the Department of Otorhinolaryngology, Sakarya University Training and Research Hospital (Sakarya, Türkiye) between 1 June 2025 and 31 December 2025. The protocol was approved by the local ethics committee (decision no. 266, 21 May 2025), and written informed consent was obtained from all participants.
Allocation and masking: Participants were allocated in a 1:1 ratio to the antibacterial suture group or the conventional suture group by block randomization. Participants were not informed of the suture type. Postoperative endoscopic assessments, scoring and structured interviews on days 7 and 21 were performed by an investigator masked to group allocation.
Intervention: Septoplasty was performed through a hemitransfixion incision with elevation of mucoperichondrial and, where necessary, mucoperiosteal flaps. Deviated cartilage and bone were corrected while preserving dorsal and caudal support (L-strut). After haemostasis, the flaps were reapproximated and transseptal sutures were placed. The incision was closed with the suture allocated to the participant: 4-0 Coated VICRYL Plus Antibacterial (triclosan-coated polyglactin 910) or 4-0 Coated VICRYL (polyglactin 910), both manufactured by Ethicon. Inferior turbinate radiofrequency reduction and/or outfracture were performed when clinically indicated. All other perioperative care, including routine antibiotic prophylaxis, was the same in both groups.
Assessments: On postoperative days 7 and 21, mucosal healing, edema, hematoma, suture-site reaction, suture material status and clinical signs of infection were assessed by nasal endoscopy and anterior rhinoscopy. Pain (visual analogue scale), nasal obstruction (validated Turkish version of the Nasal Obstruction Symptom Evaluation scale) and comfort items (relief of nasal obstruction, intranasal pressure sensation, return to daily activities and overall comfort) were collected in a structured face-to-face interview.
Registration note: This trial was registered retrospectively, after completion of enrolment and follow-up and before submission of the results for publication. The ethics-approved protocol did not designate a single primary endpoint. The primary outcome measures in this record correspond to the main objectives stated in the protocol (wound healing, infection, pain and comfort), and all between-group comparisons are reported as exploratory.
- Being tested
- Triclosan-Coated Polyglactin 910 Suture, Conventional Polyglactin 910 Suture
- Keywords
- Septoplasty, Triclosan, Antibacterial suture, Polyglactin 910, Nasal mucosa, Wound healing, NOSE scale
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan-Coated Polyglactin 910 SutureDevice
4-0 braided, absorbable polyglactin 910 suture coated with triclosan, used to close the septal incision at the end of septoplasty. All other surgical steps and perioperative care were identical to the comparator arm.
Conventional Polyglactin 910 SutureDevice
4-0 braided, absorbable polyglactin 910 suture without antibacterial coating, of the same size, used in the same way to close the septal incision.
| Study group | Role | What they receive |
|---|---|---|
| Antibacterial Suture | Experimental | Septoplasty with closure of the hemitransfixion incision using 4-0 triclosan-coated polyglactin 910 suture (Coated VICRYL Plus Antibacterial). Receives: Device: Triclosan-Coated Polyglactin 910 Suture |
| Conventional Suture | Active comparator | Septoplasty with closure of the hemitransfixion incision using 4-0 uncoated polyglactin 910 suture of the same size (Coated VICRYL). Receives: Device: Conventional Polyglactin 910 Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Healing Grade at the Septal Incision
Healing of the septal incision and mucosal flaps assessed by nasal endoscopy and anterior rhinoscopy by an assessor masked to group allocation, graded as 1 = normal, 2 = delayed, 3 = inflamed healing. Lower grades indicate better healing.
Measured: Postoperative day 7 and postoperative day 21
Number of Participants With Clinical Signs of Surgical Site Infection
Presence of local edema, erythema, purulent or serous discharge, or tissue tenderness at the operated septum, recorded as present or absent by an assessor masked to group allocation.
Measured: Postoperative day 7 and postoperative day 21
Postoperative Pain Intensity on a Visual Analogue Scale (VAS)
Pain rated by the participant on a 0-10 visual analogue scale (0 = no pain, 10 = unbearable pain). Higher scores indicate worse pain.
Measured: Postoperative day 7 and postoperative day 21
Overall Postoperative Comfort Score
Overall comfort rated by the participant on a 5-point Likert scale (range 1-5) in a structured face-to-face interview. Higher scores indicate greater comfort.
Measured: Postoperative day 7 and postoperative day 21
Secondary outcomes (8)
Edema Score at the Surgical Site
Edema at the septal incision graded by nasal endoscopy by a masked assessor as 0 = none, 1 = mild, 2 = moderate, 3 = severe. Higher scores indicate more edema.
Measured: Postoperative day 7 and postoperative day 21
Number of Participants With Septal Hematoma
Presence of septal hematoma on endoscopic examination, recorded as present or absent.
Measured: Postoperative day 7 and postoperative day 21
Suture-Site Reaction
Reaction at the suture line on endoscopic examination, categorized as none, erythema, granulation tissue or wound dehiscence (number of participants in each category).
Measured: Postoperative day 7 and postoperative day 21
Suture Material Status
Status of the suture material on endoscopic examination, categorized as in situ, broken or dislodged (number of participants in each category).
Measured: Postoperative day 7 and postoperative day 21
Nasal Obstruction Symptom Evaluation (NOSE) Score
Validated Turkish version of the NOSE scale: five items scored 0-4, raw total 0-20. Higher scores indicate worse nasal obstruction.
Measured: Postoperative day 7 and postoperative day 21
Relief of Nasal Obstruction Score
Rated by the participant on a 5-point Likert scale (range 1-5). Higher scores indicate greater relief of nasal obstruction.
Measured: Postoperative day 7 and postoperative day 21
Intranasal Pressure Sensation Score
Rated by the participant on a 5-point Likert scale (range 1-5). Higher scores indicate a more favourable status (less intranasal pressure sensation).
Measured: Postoperative day 7 and postoperative day 21
Return to Activities of Daily Living Score
Rated by the participant on a 5-point Likert scale (range 1-5). Higher scores indicate an easier return to daily activities.
Measured: Postoperative day 7 and postoperative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Septal DeviationStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated in a 1:1 ratio to one of two parallel groups (antibacterial suture or conventional suture).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Halil Elden, MD, Principal investigator, Sakarya University Training and Research HospitalOguz Kadir Egilmez, MD, Study director, Sakarya University Faculty of Medicine, Department of Otorhinolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919496
- Sponsor's protocol ID
- 21.05.2025-266
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Triclosan-Coated Versus Conventional Polyglactin 910 Sutures on Postoperative Mucosal Healing, Infection, Pain and Patient Comfort After Septoplasty: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07919496
- Acronym / sponsor ID
- 21.05.2025-266
- Keywords
- Septoplasty, Triclosan, Antibacterial suture, Polyglactin 910, Nasal mucosa, Wound healing, NOSE scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Nov 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 learn whether an antibacterial (triclosan-coated) suture improves healing after septoplasty in adults, compared with a conventional suture of the same material. The main questions it aims to answer are:
- Does the triclosan-coated suture improve healing of the nasal lining and reduce signs of infection on days 7 and 21 after surgery?
- Does it reduce pain and improve comfort after surgery?
Researchers compared triclosan-coated polyglactin 910 sutures (Coated VICRYL Plus Antibacterial) with uncoated polyglactin 910 sutures (Coated VICRYL) to see whether the antibacterial coating affects healing, infection, pain and comfort.
Participants:
- Underwent elective septoplasty and were randomly assigned to one of the two suture types, without knowing which one was used
- Attended follow-up visits on days 7 and 21 after surgery, where the nose was examined with an endoscope by an examiner who did not know the suture type
- Rated their pain, nasal blockage and comfort at the same visits
Detailed description
Design and setting: Single-centre, prospective, randomized, controlled, parallel-group trial conducted in the Department of Otorhinolaryngology, Sakarya University Training and Research Hospital (Sakarya, Türkiye) between 1 June 2025 and 31 December 2025. The protocol was approved by the local ethics committee (decision no. 266, 21 May 2025), and written informed consent was obtained from all participants.
Allocation and masking: Participants were allocated in a 1:1 ratio to the antibacterial suture group or the conventional suture group by block randomization. Participants were not informed of the suture type. Postoperative endoscopic assessments, scoring and structured interviews on days 7 and 21 were performed by an investigator masked to group allocation.
Intervention: Septoplasty was performed through a hemitransfixion incision with elevation of mucoperichondrial and, where necessary, mucoperiosteal flaps. Deviated cartilage and bone were corrected while preserving dorsal and caudal support (L-strut). After haemostasis, the flaps were reapproximated and transseptal sutures were placed. The incision was closed with the suture allocated to the participant: 4-0 Coated VICRYL Plus Antibacterial (triclosan-coated polyglactin 910) or 4-0 Coated VICRYL (polyglactin 910), both manufactured by Ethicon. Inferior turbinate radiofrequency reduction and/or outfracture were performed when clinically indicated. All other perioperative care, including routine antibiotic prophylaxis, was the same in both groups.
Assessments: On postoperative days 7 and 21, mucosal healing, edema, hematoma, suture-site reaction, suture material status and clinical signs of infection were assessed by nasal endoscopy and anterior rhinoscopy. Pain (visual analogue scale), nasal obstruction (validated Turkish version of the Nasal Obstruction Symptom Evaluation scale) and comfort items (relief of nasal obstruction, intranasal pressure sensation, return to daily activities and overall comfort) were collected in a structured face-to-face interview.
Registration note: This trial was registered retrospectively, after completion of enrolment and follow-up and before submission of the results for publication. The ethics-approved protocol did not designate a single primary endpoint. The primary outcome measures in this record correspond to the main objectives stated in the protocol (wound healing, infection, pain and comfort), and all between-group comparisons are reported as exploratory.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were allocated in a 1:1 ratio to one of two parallel groups (antibacterial suture or conventional suture).
| Arm | Type | Receives |
|---|---|---|
| Antibacterial Suture | Experimental | Device: Triclosan-Coated Polyglactin 910 SutureSeptoplasty with closure of the hemitransfixion incision using 4-0 triclosan-coated polyglactin 910 suture (Coated VICRYL Plus Antibacterial). |
| Conventional Suture | Active comparator | Device: Conventional Polyglactin 910 SutureSeptoplasty with closure of the hemitransfixion incision using 4-0 uncoated polyglactin 910 suture of the same size (Coated VICRYL). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years
- Scheduled for elective septoplasty for nasal septal deviation
- American Society of Anesthesiologists (ASA) physical status I or II
- Voluntary participation with written informed consent
- Able to communicate, understand and respond in Turkish
Key exclusion criteria (7 listed)
- Age younger than 18 or older than 65 years
- Cognitive impairment precluding interviews, or inability to cooperate
- Uncontrolled systemic disease
- Immunosuppression
- Active local or systemic infection before surgery
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 |
|---|---|---|
| Triclosan-Coated Polyglactin 910 Suture4-0 braided, absorbable polyglactin 910 suture coated with triclosan, used to close the septal incision at the end of septoplasty. All other surgical steps and perioperative care were identical to the comparator arm. | Device | Antibacterial Suture |
| Conventional Polyglactin 910 Suture4-0 braided, absorbable polyglactin 910 suture without antibacterial coating, of the same size, used in the same way to close the septal incision. | Device | Conventional Suture |
Primary outcome
Mucosal Healing Grade at the Septal Incision
Time frame: Postoperative day 7 and postoperative day 21
Healing of the septal incision and mucosal flaps assessed by nasal endoscopy and anterior rhinoscopy by an assessor masked to group allocation, graded as 1 = normal, 2 = delayed, 3 = inflamed healing. Lower grades indicate better healing.
Number of Participants With Clinical Signs of Surgical Site Infection
Time frame: Postoperative day 7 and postoperative day 21
Presence of local edema, erythema, purulent or serous discharge, or tissue tenderness at the operated septum, recorded as present or absent by an assessor masked to group allocation.
Postoperative Pain Intensity on a Visual Analogue Scale (VAS)
Time frame: Postoperative day 7 and postoperative day 21
Pain rated by the participant on a 0-10 visual analogue scale (0 = no pain, 10 = unbearable pain). Higher scores indicate worse pain.
Overall Postoperative Comfort Score
Time frame: Postoperative day 7 and postoperative day 21
Overall comfort rated by the participant on a 5-point Likert scale (range 1-5) in a structured face-to-face interview. Higher scores indicate greater comfort.
8 secondary outcomes
Edema Score at the Surgical Site
Time frame: Postoperative day 7 and postoperative day 21
Number of Participants With Septal Hematoma
Time frame: Postoperative day 7 and postoperative day 21
Suture-Site Reaction
Time frame: Postoperative day 7 and postoperative day 21
Suture Material Status
Time frame: Postoperative day 7 and postoperative day 21
Nasal Obstruction Symptom Evaluation (NOSE) Score
Time frame: Postoperative day 7 and postoperative day 21
Relief of Nasal Obstruction Score
Time frame: Postoperative day 7 and postoperative day 21
Intranasal Pressure Sensation Score
Time frame: Postoperative day 7 and postoperative day 21
Return to Activities of Daily Living Score
Time frame: Postoperative day 7 and postoperative day 21
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author.
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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.
Halil Elden, MD principal investigator
Sakarya University Training and Research Hospital
Oguz Kadir Egilmez, MD study director
Sakarya University Faculty of Medicine, Department of Otorhinolaryngology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triclosan-Coated Polyglactin 910 Suture and Conventional Polyglactin 910 Suture in people with Nasal Septal Deviation and Surgical Wound Healing, run by Sakarya University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 5 Nov 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 Turkey (Türkiye). 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?
Mucosal Healing Grade at the Septal Incision (time frame: Postoperative day 7 and postoperative day 21). The study lists 4 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 5 Nov 2026.