Silastic Sheet Usefulness Following Septoplasty

Septoplasty Clinical Trial

Official title:

Silastic Sheet Usefulness Following Septoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04921462
• Other study ID #: RC20/509
• Status: Completed
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: June 2021
• Source: King Abdulaziz Medical City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 4, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septoplasty

Intervention

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.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz Medical City

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NOSE score 1 month postoperatively	NOSE change = preoperative NOSE - 1 month postoperative NOSE	1 month postoperatively
Secondary	Validated NOSE score		NOSE score preoperatively, 3 days, 1 week and 1 month postoperatively
Secondary	complications	Bleeding, Bad smell, Synechia, Crustation and Perforation	1 month
Secondary	postoperative pain	using numerical Pain scale (0 to 10)	at 3 days postoperative
Secondary	general satisfaction questionnaire		at 1 month postoperative