Silastic Sheet Usefulness Following Septoplasty

King Abdulaziz Medical City

Status: Completed

Conditions: Septoplasty

Treatments: Procedure: Septoplasty surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04921462

RC20/509

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Silastic group

Active Comparator group

Description:

included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint

Treatment:

Procedure: Septoplasty surgery

Quilting group

Active Comparator group

Description:

included patients who underwent septoplasty followed by quilting suture (Septal through and through suture)

Treatment:

Procedure: Septoplasty surgery

Sponsor of this trial

Lead Sponsor

King Abdulaziz Medical City