Silastic Sheet Usefulness Following Septoplasty

June 9, 2021 updated by: Leen Hijazi, King Abdulaziz Medical City

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 14611
        • King Abdulaziz Medical City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silastic group
included patients who underwent nasal septoplasty followed by insertion of silastic intranasal splint
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.
Active Comparator: Quilting group
included patients who underwent septoplasty followed by quilting suture (Septal through and through suture)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz Medical City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

May 4, 2021

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC20/509

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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