Silastic Sheet Usefulness Following Septoplasty

Not Applicable

Completed

• Conditions: Septoplasty
• Interventions: Procedure: Septoplasty surgery

• Registration Number: NCT04921462
• Lead Sponsor: King Abdulaziz Medical City

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-29
• Primary Completion: 2021-03-31
• Study Completion: 2021-05-04
• Status Verified: 2021-06
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silastic group	Septoplasty surgery	included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint
Quilting group	Septoplasty surgery	included patients who underwent septoplasty followed by quilting suture (Septal through and through suture)

Primary Outcome Measures

Name	Time	Method
Change in NOSE score 1 month postoperatively	1 month postoperatively	NOSE change = preoperative NOSE - 1 month postoperative NOSE

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King Abdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia