Silastic Sheet Usefulness Following Septoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Silastic Sheet Usefulness Following Septoplasty

Conditions
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Septoplasty

Intervention / Treatment
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* Procedure: Septoplasty surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (≥ 18 years) healthy individuals of both genders with deviated nasal septum and no other concomitant procedures. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silastic group<br>included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint | Procedure: Septoplasty surgery<br>* 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.<br>|
| Active Comparator: Quilting group<br>included patients who underwent septoplasty followed by quilting suture (Septal through and through suture) | Procedure: Septoplasty surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NOSE score 1 month postoperatively | NOSE change = preoperative NOSE - 1 month postoperative NOSE | 1 month postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated NOSE score |  | NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively | 
| complications | Bleeding, Bad smell, Synechia, Crustation and Perforation | 1 month | 
| postoperative pain | using numerical Pain scale (0 to 10) | at 3 days postoperative | 
| general satisfaction questionnaire |  | at 1 month postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NOSE score, Intranasal splint, Silastic sheet, quilting suture