ClinicalTrials.gg
CompletedNCT07919496Updated Nov 5, 2026

Antibacterial (Triclosan-Coated) Versus Conventional Sutures in Septoplasty

An interventional study of Triclosan-Coated Polyglactin 910 Suture and Conventional Polyglactin 910 Suture in Nasal Septal Deviation, Surgical Wound Healing and Surgical Site Infection, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Sakarya University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jun 2025, registered Oct 2026).
Updated Nov 5, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 31 studies in Surgical Wound Infection with a site in Turkey — 10 open to participants now, 14 under way, none of them phase 3. Surgical Wound Infection · Turkey.

Enrollment
7th of 26
142 · median 89
Started
2025
with 4 others
No phase
24 of 31
7 open now
Registered
31st of 31
by date
Lead sponsor
2 of 31
Sakarya University

Among the 31 studies in Surgical Wound Infection with a site in Turkey, this one is the 7th largest by enrollment of the 26 interventional ones that give a count, is one of 5 that started in 2025, is one of 24 with no phase, and was the 31st registered.

Surgical Wound Infection

746 studies on the registry are indexed under Surgical Wound Infection; 152 are open to participants now.

Browse Surgical Wound Infection studies →

Open to participants now

10 of the 31 studies in Surgical Wound Infection with a site in Turkey are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Surgical Wound Infection with a site in Turkey, or all of them as a file.
02

Study 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. 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
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.

03

Conditions studied

  • Nasal Septal Deviation
  • Surgical Wound Healing
  • Surgical Site Infection

Keywords

  • Septoplasty
  • Triclosan
  • Antibacterial suture
  • Polyglactin 910
  • Nasal mucosa
  • Wound healing
  • NOSE scale
04

Who can participate

Ages eligible
18 Years to 65 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

  • Age 18 to 65 years
  • Scheduled for elective septoplasty for nasal septal deviation
  • (ASA) physical status I or II
  • Voluntary participation with written
  • Able to communicate, understand and respond in Turkish
  • No hearing or speech impairment severe enough to interfere with the assessments

Exclusion criteria

Exclusion Criteria:

  • Age younger than 18 or older than 65 years
  • Cognitive impairment precluding interviews, or inability to cooperate
  • Uncontrolled systemic disease
  • 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
Terms in these criteria, in plain language(3)

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
142 participants (actual)

Study arms

  • Experimental
    Antibacterial Suture

    Septoplasty with closure of the hemitransfixion incision using 4-0 triclosan-coated polyglactin 910 suture (Coated VICRYL Plus Antibacterial).

    Device: Triclosan-Coated Polyglactin 910 Suture

  • Active comparator
    Conventional Suture

    Septoplasty with closure of the hemitransfixion incision using 4-0 uncoated polyglactin 910 suture of the same size (Coated VICRYL).

    Device: Conventional Polyglactin 910 Suture

Interventions

  • DeviceTriclosan-Coated Polyglactin 910 Suture

    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.

  • DeviceConventional Polyglactin 910 Suture

    4-0 braided, absorbable polyglactin 910 suture without antibacterial coating, of the same size, used in the same way to close the septal incision.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  2. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  3. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  4. 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.

    Time frame: Postoperative day 7 and postoperative day 21

Secondary outcomes

  1. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  2. Number of Participants With Septal Hematoma

    Presence of septal hematoma on endoscopic examination, recorded as present or absent.

    Time frame: Postoperative day 7 and postoperative day 21

  3. 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).

    Time frame: Postoperative day 7 and postoperative day 21

  4. Suture Material Status

    Status of the suture material on endoscopic examination, categorized as in situ, broken or dislodged (number of participants in each category).

    Time frame: Postoperative day 7 and postoperative day 21

  5. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  6. 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.

    Time frame: Postoperative day 7 and postoperative day 21

  7. 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).

    Time frame: Postoperative day 7 and postoperative day 21

  8. 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.

    Time frame: Postoperative day 7 and postoperative day 21

07

Study locations

1 site
  • Sakarya University Training and Research Hospital, Department of Otorhinolaryngology
    Sakarya, 54100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author.

Supporting information: Study protocol

Time frame: From publication of the main results, for 5 years.

Access criteria: Requests are reviewed by the principal investigator. Data are shared after approval of a methodologically sound proposal and signature of a data-sharing agreement, in accordance with Turkish personal data protection legislation.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Dec 2025, 6 months.

Of 201 non-industry interventional studies with no phase under Surgical Wound Infection, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 6 months is below that.

Counting every sponsor, half of 208 studies reached it within 24 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2026
First posted
Nov 5, 2026
StartActual
Jun 1, 2025
Primary completionActual
Dec 31, 2025
CompletionActual
Dec 31, 2025
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07919496
Lead sponsor
Sakarya University
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Jun 1, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Nov 5, 2026

Study contacts

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

Oversight

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

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