SeptoplastyNCT04921462
Silastic Sheet Usefulness Following Septoplasty
A study testing Septoplasty surgery in people with Septoplasty, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
Trial summary
This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique. Methods: A single center randomized controlled trial, including adult above the age of 18. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septoplasty
- What is being tested?
- Septoplasty surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Sep 2020to 4 May 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.
Who cannot join
- 1. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.
Methods:
A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.
- Conditions
- Septoplasty
- Being tested
- Septoplasty surgery
- Keywords
- Intranasal splint, Silastic sheet, quilting suture, NOSE score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septoplasty surgeryProcedure or surgery
septoplasty procedures were performed by a single surgeon using the same technique among all patients. The procedures were conducted under general anesthesia according to the standard preoperative care used in our institution.
| Study group | Role | What they receive |
|---|---|---|
| Silastic group | Active comparator | included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint Receives: Procedure: Septoplasty surgery |
| Quilting group | Active comparator | included patients who underwent septoplasty followed by quilting suture (Septal through and through suture) Receives: Procedure: Septoplasty surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NOSE score 1 month postoperatively
NOSE change = preoperative NOSE - 1 month postoperative NOSE
Measured: 1 month postoperatively
Secondary outcomes (4)
Validated NOSE score
Measured: NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively
complications
Bleeding, Bad smell, Synechia, Crustation and Perforation
Measured: 1 month
postoperative pain
using numerical Pain scale (0 to 10)
Measured: at 3 days postoperative
general satisfaction questionnaire
Measured: at 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start29 Sep 2020
- Primary completion31 Mar 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeptoplastyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leen Hijazi, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921462
- Sponsor's protocol ID
- RC20/509
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 10 Jun 2021
- 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 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silastic Sheet Usefulness Following Septoplasty
- ClinicalTrials.gov ID
- NCT04921462
- Acronym / sponsor ID
- RC20/509
- Conditions
- Septoplasty
- Keywords
- Intranasal splint, Silastic sheet, quilting suture, NOSE score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Abdulaziz Medical CityOther government
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 10 Jun 2021 (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.
This study aimed to evaluate the effectiveness of silastic septal splint in reducing the rates of complications, decreasing the post-operative pain, and improving satisfaction in comparison to quilting suturing technique.
Methods:
A single center randomized controlled trial, including adult above the age of 18. A total of 50 participants who underwent septoplasty were enrolled and randomly assigned into two groups, Silastic group (n=25), and quilting group (n=25). Nasal obstruction severity was assessed by using an Arabic validated version of NOSE score, preoperatively then 3 days, one week and one month postoperatively. Post-operative complications were assessed at outpatient clinic 1 week and 1 month postoperatively. Pain was assessed by a 10-point numerical scales via phone call on the 3rd day postoperative.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silastic group | Active comparator | Procedure: Septoplasty surgeryincluded patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint |
| Quilting group | Active comparator | Procedure: Septoplasty surgeryincluded patients who underwent septoplasty followed by quilting suture (Septal through and through suture) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures.
Key exclusion criteria (1 listed)
- 1. Concomitant procedure other than septoplasty. 2. Previous history of septal or nasal surgery. 3. Presence of nasal polyps, chronic sinusitis or other regional pathology. 4. Bleeding disorders or anticoagulation therapy.
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 |
|---|---|---|
| Septoplasty surgeryseptoplasty procedures were performed by a single surgeon using the same technique among all patients. The procedures were conducted under general anesthesia according to the standard preoperative care used in our institution. | Procedure or surgery | Quilting group, Silastic group |
Primary outcome
Change in NOSE score 1 month postoperatively
Time frame: 1 month postoperatively
NOSE change = preoperative NOSE - 1 month postoperative NOSE
4 secondary outcomes
Validated NOSE score
Time frame: NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively
complications
Time frame: 1 month
postoperative pain
Time frame: at 3 days postoperative
general satisfaction questionnaire
Time frame: at 1 month postoperative
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 10 Jun 2021.
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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 Septoplasty surgery in people with Septoplasty, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
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 1 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 10 Jun 2021. 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 Saudi Arabia. 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?
Change in NOSE score 1 month postoperatively (time frame: 1 month postoperatively). 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 10 Jun 2021.