NCT04921462

Silastic Sheet Usefulness Following Septoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: King Abdulaziz Medical City · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Septoplasty

Interventions

Type	Name	Description
PROCEDURE	Septoplasty 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.

Timeline

• Start date: 2020-09-29
• Primary completion: 2021-03-31
• Completion: 2021-05-04
• First posted: 2021-06-10
• Last updated: 2021-06-10

Locations

1 site across 1 country: Saudi Arabia